8/26/10 DePuy Orthopaedics, a division of Johnson & Johnson, has announced that it is recalling two types of hip implants because of higher-than-expected early failure rates.
The recall affects the ASR XL Acetabular System, which is used for total hip replacements, and the ASR Hip Resurfacing System, which is used in a newer kind of bone-conserving procedure.
The total hip replacement system was FDA approved and has been used in patients in the United States.
The hip resurfacing system has not been approved for use in this country, but according to company spokeswoman Lorie Gawreluk, some patients in the U.S. have gotten the implants through a clinical trial.
Also, people who have traveled outside of the U.S. for hip resurfacing or hip replacement procedures may have been fitted with ASR components.
A combined total of about 93,000 of the devices have been implanted worldwide.
DePuy said that it was issuing the voluntary recall after new data from a British joint replacement registry showed about 1 in 8, or around 12 percent, of those who received the implants needed corrective procedures, called revision surgeries, within five years.
That failure rate appears to be about twice the industry average, says Kevin J. Bozic, MD, an orthopaedic surgeon and vice chairman of orthopaedics at the University of California at San Francisco Medical Center, who has studied revision rates in hip replacement.
"It was a design failure that frankly wasn’t picked up until they were implanted in thousands of patients," Dr. Bozic says.
"This really underscores the need to track outcomes in hip and knee replacement patients. We happen to be one of the only developed countries in the world that doesn't track joint replacements through a patient registry," he adds.
Most people who replace a hip or knee can expect their new implants to last for the rest of their lives.
But in some cases, usually because of loosening, when the components detach from the bone, infection or dislocation, implants have to be removed and replaced in a revision surgery.
Revisions are more complicated and costly than primary joint replacements because surgeons have less bone and more scar tissue to work with.
Signs that the implant may be failing include pain and difficulty walking.
But the company is advising people who know they have ASR implants to schedule follow-up appointments with their surgeons, whether or not they are experiencing problems.
Doctors will evaluate how the implants are functioning and may give patients blood tests to check for signs of microscopic metal particles around the implant, a sign of abnormal wear.
Dr. Bozic says the important thing for consumers to remember is that most implants, even the ones affected by this recall, function well and are safe.
But he acknowledges that this recall has already generated a lot of anxiety among people with hip replacements: "A recall is a huge deal."
He says his practice has already operated on people who have not been having trouble with their ASR implants, but who wanted to get them removed for fear of future problems.
For more information, including instructions on how to find out if you have an ASR implant, click here to go to the ASR recall web site.
The company will also take questions through a toll-free phone number: 888-627-2677.
now I'm having pain in my chest and groin, vision and hearing loss,and walking is becoming
more difficult. My cobalt and chromium levels
are very high. Cobalt is 17.0, What should my
next step be? Where or how to proceed- How do
I find a good attorney experienced in this?
Any help will be appreciated. Thank you!
John G.
I live in WI.
J & J - thanks for owning up. If I see how many people suffer with HR failures with other products, we do appreciate it.
NOW, the big question - how long do we have to wait to ensure that Revision(1) will not fail as well?
I have to have another operation and its been 6 months sense they found the broke pin sad its like they dont care because they make it so hard to start a lawsuit in florida Im disabled because of this couldnt finish physical therapy because of the pain lost rang of motion knees wont bend all the way cant sleep all night its a night mare how can i find out who makes the titanium rods for femur fractur my email is mhopeforever@yahoo.com
The process is painful and requires a lot of patience but with the right help you can make it through.
Thank you!!
thanks Margaret
On 3/29/2010, I had a hip replacement using a Depuy Pinnacle and 3-4 days after surgery I developed a severe rash from my hip to my ankle and there was a excessive amount of drainage from the incision. I spoke to the surgeon several times and he was not concerned (although I continued to go back to him 12 times alerting him of my ongoing pain and he kept saying give it time and my pain was probably due to "end of stem" pain). I continued to have unexplained ongoing pain with the prothesis which never subsided. I read about metal allergies and thought it may be the source of my pain so I made an appointment with a doctor in Chicago whose research includes this type of reaction/research. I was tested for several alloys, incuding chromium, titanium and nickel. It was determined that I was allergic to nickel. Armed with this information, I took this to my orthopedic surgeon and he contiuned to dismiss this theory and my ongoing pain for a year until the 1 year anniversary date where he determined the stem was loose and that's what was causing my pain. Thank goodness, I did more research and contacted the doctor in Chicago and asked for suggested doctors in my area doing revision surgery. I was given a name of a orthopedic surgeon at the University of Maryland Medical Center and upon one meeting with him, I was reassured that he was the surgeon I wanted for my revision surgery. I had the revision surgery about 3 weeks ago and this is what he found: Upon opening me up, he found an abundance of thin yellow fluid and once infection was excluded, it was determined to be caused by my reaction to the nickel in my prothesis. I was extremely happy that the problem had been solved; however, I was also very anrgry as I had just spent a year trying to convince the original orthopedic surgeon (12 visits) that my pain may be due to the nickel allergy where he continued to dismiss me (he even said at one of the office visits "you know I did go to medical school" when I brought along several medical articles regaring metal allergies. This new surgeon solves my problem in one office visit and the revision surgery!!! Furthermore, the allergy destroyed 4 inches of my femur bone requiring a bone graft, required a 4 plus hour surgery, required 6 pints of blood and a large amount of heterotopic ossification was found which my new surgeon removed and gave me a dose of radiation to try to prevent it this time. Therefore, the moral to my story is if you have a metal on metal prothesis with unexplained pain, please get tested for metal allergy. For more information on metal testing, please take a look at this site: http://www.orthopedicanalysis.com
Alas, all these Dr's know is what DePuy tells them but put 2+2 together and realize that if these hips from DePuy were all made by the same 'DePuy' outfit they all contain the same same amount of toxins. One does not need a half a dozen degrees behind their name to figure that one out. It goes even further than that a very active person will put out more Cobalt than a inactive sedentary senior for obvious reasons. And sadly we do not know how quickly the Cobalt leaves the body after the source is removed.
The reason some have a higher incidence than other I suspect is body chemistry. Men vs women may be one reason higher in women I was told. Again, get a Cobalt level blood draw right away,then go on in you inquiry as to your situation. So if you do not have the exact device you have, you will know if you have a saturation of Cobalt in your body.
Where medicine has gone in America is a shame, and what is further a shame that one of the Orthopedic Doctors in our community received over one million dollars from DePuy for using DePuys devices. Can you believe that one. Google DePuy Orthopedics, Inc. Payments to Orthopedic Surgeons and Hospitals. That is an eye opener for sure!
We were 36 months post op before we were notified about the recall. It has been another nightmare since!
Mary Pat RN
I had a Depuy ASR put in my hip 2/6/09, It has been wonderful never had any pain after the surgery, very active, tennis, yoga, hiking, and good flexibility. But I just had my metal blood test done and my cobalt and chromium levels are very high, which has really got me nervous. I am going in for an MRI to check the hip and see if all is o.k. I wonder if there is anything that you can take to detox the metals out of your body?
Help is this a defect?
Asked for medical records, but it they didn't have the info of which told me what I wanted to know...finally Dr. told me what to ask for...the surgeon papers from the actual surgery...July 2005...DuPuy...do not know any specifics of which of these are the recalled lots or if any are...but something not right...where do we go from here?
I am still waiting anxiosly along with my family.
Anthony Sobey all very strange ???????
The FDA reported that companies such as Johnson and Johnson / subsidary of DePuy Orthopedics and others have issued a voluntary recall of it's hip replacement systems.
If you have had a hip replacement you are most likely eligible for large compensation.
Here is a great resource to help you get the compensation you deserve.
Go Here:
referer.us/8/BCrHZ
My hip has never been the same since my surgery! =(
GOOD LUCK TO YOU ALL
JIM MORELAND
Now...PAIN...up all night can barly see to type this. insurance does not want to pay for hospital with out hip dislocating or loosing.
Mri, bone scan, xrays are all clear, yet blood test shows extremly high levels of cobalt poison. I am losing eye sight,hearing, cognitive abilities, confused, nausia, no appitie ect.
Ortho doc ready to do revision, insurance will pay him but not the hospital with out another document.
Went to my primary doctor today because insurnace needs documented proof of pysical symptoms of poison. Doc told me today when I had to use a cane to almost crawl in their office... to go to the emergency room, because colbalt is making me sicker, ya think!I know this doc and others are shying away because of lawsuit with depuy. Can't blame them, but ugh!
Advice to all God will show mercy on us all, and give back what Depuy knowingly over and over has gotten rich on at the stake of our lives those of us who believe our Lord can heal, believe also he will recompence for such pain and loss.
Do not sign anything with Depuy, Do not register ur hip with any registry.
Make sure you tell ur lawyer when ur going into surgery and keep that hip, it is the proof for the lawsuit. Take care! iam on my way to the emergency room.
Margaret Hurley
Email: margaret.hurley@emailourfamily.com
I had my left and right hip replaced with 7 additional surgeries on the right hip. Below is a rough summary of my hip replacements.
LEFT HIP as follows:
On 6/16/2005 I had a left hip replacement due to degenerative joint disease. This was done at Erlanger Hospital in Chattanooga TN by Dr Dale Ingram. I still have this implant in my body.
Left Hip Replacement Components are as follows: 6/16/2005:
Device Description: Femoral Stem Tapered w/Porocoat…Manufacturer: Depuy. Catalog # 1570-01-090. Model: Summit.
Device Description: Hip Head. Manufacturer: Depuy. Catalog # 1365-11-000. Model: Articuleze.
Device Description:Acetabular Cup. Manufacturer: Depuy. Catalog # 1217-22-048. Model: Pinnacle Sector 2.
Device Description: Acetabular Liner-Lipped. Manufacturer: Depuy. Catalog # 1219-28-248. Model: Pinnacle Marathon.
The left hip after it was put in naturally hurt when it rained…if it was to cold….if I walked a lot or did a lot of physical work but pretty much it was ok….considering the pain I was in before the hip was replaced anything would have been better, I could hardly walk when I finally had it replaced. At first it was just a naggging ache, then gradually the pain has gotten worse and worse that now I am in such pain that it makes me throw up…I can’t sit thru a complete meal w/o having to get up due to extreme pain, I can’t sleep all night long as the pain wakes me up several times throughout the night….I guess you get the point. There is no words to tell you how bad the pain is. I hope something can be done to fix it! And to top it off …My insurance Company denied the surgery (at least after I had the surgery) and I was sued and have a Court Order where I have to pay $30,000. To the hospital that did the surgery as stated above….So not only does the hip not work but I pay forever the bad hip BUT now SOMETHING has to be done to fix it! WOW…THAT HURTS!!!
RIGHT HIP as follows:
On 10/3/2007 I had my right hip replaced due to degenerative joint disease. This was done at Baptist Hospital in Murfreesboro, TN by Dr McKissick. The hip implant done 10/3/2007 was revised. Here is a rough summary of my Right Hip Replacements.
Right Hip Replacement Components are as follows: 10/3/2007:
Complications:
There was a split along the medial aspect of the calcar when placing the trial stem. This was reinforced with a cerclage cable.
Implants:
1) Smith and Nephew Emporion size 13 regular offset stem
2) Emperion size 13 small #1 sleeve
3) Reflection InterFit 48-mm acetabulm with two 20-mm screws and one 40-mm screw. A 48-mm cross length poly liner with a 20-degree lip.
4) A 28-mm + 0 Oxinium head.
5) Cable grip and 1 Zimmer cerclage cable.
After the hip replacement in 2007 I was in constant pain.I felt sick all the time….low grade fevers…just YUKKY! I couldn’t understand why I was always in pain and felt so yukky after I had a new hip. I learned Dr McKissick messed up and put a stainless steel cable (the manufacturer is Zimmer) around the femur (he cracked the femur putting the trial stem in). I AM HIGHLY ALLERGIC TO STAINLESS STEEL! I felt lost because I was in pain and had no answers why. Dr McKissick didn’t know what to do with me anymore and due to the pain meds I was passed onto a Pain Dr to handle my pain meds and as I was told….s “sometimes people have unexplained pain after a major surgery like hip replacements”.
Anyway...Dr McKissick passed me to Dr Son Le….Spine Joint & NeuroMuscular Rehabilitation in Nashville, TN.
Dr Le/the pain Dr in turn referred me to
Dr J. Craig Morrison at St. Thomas Hospital in Nashville, TN that specializes in revisions. The Dr and I decided that possibly my pain was from the stainless steel cable which I was Allergic to, so he decided to take the cable out to see if I feel better. On 3/5/2009 Dr Morrison took me to surgery for Removal of the Hardware…the cable. Within a couple days I started swelling …like I had a baseball growing in my right hip. As the swelling continued to grow and HURT…Dr Morrison took me back to surgery on 3/16/2009 for an I & D of the right hip thinking it was a Staph infection. I was put on a PIC Line with a strong antibiotic (months & months I had that PIC Line!!)The swelling came back and kept swelling…now……like a softball was growing on the right hip. On 4/15/2009 Dr Morrison took me back to surgery…this time for I & D and Revision Total Hip Arthroplasty. I left the hospital again on 4/20/2009. Then on 4/25/2009 I went back to the hospital (and now it looked like a watermelon was growing at my right hip) for Acute Bleeding. And I went home and the swelling came back again/still/never went away. On 6/1/2009I went back into the hospital for Resection of the right hip where the Dr still saying it was a Staph infection where Dr Morrison put in a Depuy Prostalac Hip System, which our understanding that it was a temporary hip filled with antibiotics. After the 6/1/2009 surgery I had issues with memory and comprehensive. I couldn’t tell my crews at my job couldn’t figure out what to do because I couldn’t figure how to tell them what to do. The Dr said it was proably Fat Embolisms that lets loose sometimes during a long surgery like that one (ALWAYS BE VERY AWARE OF YOUR POSSIBLE COMPLICATIONS!). Anyway……. The swelling continued still and the Dr was at a loss though he kept tell my husband and I that it was an infection! So on 9/21/2009 Dr Morrison took me back to surgery to take the complete hip…all components…all glue…everything out to see if my hip would heal. After sitting for 4 weeks without a hip at all (and MAN... was that scary…having no hip at all!) on 10/19/2009 Dr Morrison took me back to surgery where he put a new hip in. My husband had to care for me and couldn’t leave me alone at all. It was impossible for him to work unless somebody came to sit with me. Since the last surgery in 2009 I have been in a lot of pain but at least the swelling is not near as bad as it was. I have pictures that show the swelling/PIC Line & stuff I went thru in 2009.
.
The current right hip implant Components are as follows 10/19/2009:
Smith and Nephew MDF System
1) Size 16-mmx240-mm conical stem
2) A 16 small modular sleeve
3) Standard neck
4) A 36+4 Oxinium femoral head
5) Smith and Nephew R3 Acetabular Shell
Size:
1) A 56-mm
2) A 36-mm inner diameter polyethylene shell
3)
Both hips hurt me so bad it is hard to focus even on simple tasks, I can’t sit very long, I can’t stand long, I cry a lot cause the pain is so bad. After losing my job and home, I couldn’t stay in one place to see why my hips hurt so bad, but now with a home again, I finally after much fighting……. I finally have an appointment with a specialist Dr Thomas Bradbury who specializes with revisions @ Emory Ortho Clinic in Atlanta.
Margaret Hurley
When I was released from therapy I was not satisfied and I determined to try some things on my own. They hurt alot in the beginning but the pain was worth the results.
I started going to CURVES and carefully planning and building my own exercise as I could tolorate each machine. I also began doing Chair Yoga. That was amazing. The stretching made such a difference. I think it broke loose some of the scar tissue and strenthened ligaments that had begun to atrophy. I also began taking shopping carts and going down each aisle in the store and gradually increased the number of times. It hurt but I learned not to go to far with my increases and not take too many days off. I also analyzed each thing I was doing to figure out what was good and what was not. If it hurt too much I stopped for a week and tried again. I think the stretching was the most helpful. I also got lifts for my shoes because one leg is longer. I realized I was always lying in the same comfortable position in bed. When I began to sleep on both sides and on my back my posture got better and everyhing got more comfortable. Once again I did not push it too fast but good posture makes a difference and my legs seem to be getting closer in lenth because I am comfortable with shorter lifts. I encourage you to try to come up with your own individual programs. We are all different in how we live our lives and our height, length of stride etc. Just go slow and gentle. I am pleased with how I am coming along. It has been about 1 1/2 years and I do get more tired but I notice I'm walking faster and things dont seem such a challenge.
Par 5 Acetabular shell 68 mm (109268)
Ring loc Acetabular Liner 32 mm (1059225)
Par 5 Obturtor Hook and Screw (109220)
Par 5 ring loc Acetabular short flange (109200)
Femoral Head w/o cartilage 4.8 cm. The others is basically four screws. my left buttocks protudes some 4mm bigger than my right, my pants fit awfully wrong, i am in constant pain, i cannot walk one inch without some sort of support, I have sent the information to my surgeons in Trinidad and all they have asked is to send a xray. I feel if you have operated twice on the same hip you should know what is wrong or what went wrong the first time around. Looking at the initial x-rays after my surgery in 2009; the left was not fitted as the right. The mechanics was simple off.
Upfront, here are serial numbers of the cup and bone screws of my
DePuy Pinnacle (metal on metal) ACE Tabular Cup full hip replacement:
1. DePuy Pinnacle ACE Tabular Cup
REF 1217-22-056 LOT C31EF1000
SZ MM 56
2. DePuy Pinnacle Cancellous Bone Screw (2 screws same serial numbers)
REF 1217-30-500 LOT AF 2E6400
DIA MM 6.5
MM LGT 30
1. My right hip was replaced using one of the DePuy devices 2 days before Christmas 2008.
2. For the first 3 months after surgery I was unable to lie down straight in bed, only changing certain positions hourly sitting in a recliner allowed me to bear severe and violent pain. Actually, to the day (almost 2 years after surgery), I am not able to sit, stand, or lie down for more than a couple of hours, rather less. Even when I don’t move at all, severe and violent pain kicks in. During that time I also was ordered physical therapy. At the time, my Physical Therapist also wondered why I still was in so much pain.
3. Once I was ordered to walk on full weight, I was never able to walk more than half a mile without severe pain kicking in. Actually, to the day my hip replaced leg starts hurting badly when I walk only very short distances, much shorter than half a mile and often when I don’t walk also. My surgeon always suggested to be patient as recovery from a severe operation like that could take up to a year, or more.
4. The last time I saw my surgeon was in January of 2010. Again, I told him how severe my pains still were. Dr. Cuff discussed a bone marrow transplant with me. A procedure that could help to fasten the stem part of my implanted hip. But Dr. Cuff recommended to stay away from that procedure as he knew of only a couple of cases and they weren't successful. On top of it I could be on crutches for another 10 to 12 months.
5. During this past spring/summer I tried to see my surgeon again. Mainly because I was suffering more and more. Unfortunately, due to my long tern ‘Leave of Absence’ I had lost my job and all my benefits including health insurance. My surgeon’s front office told me over the phone that I would have to pay a fee of $160 just to see the doctor as an uninsured person. I simply could not afford that at the time.
6. After I learned that I have a ACE tabucular cup hip replacement made by Depuy Orthopedics, I went to the Venice Regional hospital in order to request my Medical Records and Implant Report. It was a kind of odd that the clerks at the hospital said that they can provide my Medical Records, but that it seemed strange that they were unable to find the serial number of my DePuy hip replacement. They told me that they would send me a copy when they would find it. After appr. 2 weeks I received a copy of the implanted system, and it states ‘DePuy Pinnacle ACE tabular’. While this device is not under the official recall, it is also a metal on metal, and many articles/blog posts by doctors, lawyers and patients talk about the same symptoms I suffer from. Supposedely, the FDA has more than 300 patient complaints on that device.
7. My medical condition, personal situation and circumstances get worst and worst.
Furthermore, and after my employer Comcast Cable had terminated me because of extended ‘Leave of Absence due to illness’, I applied for unemployment benefits. Unemployment was denied because the agency was not able to help me because of my illnesses. Since surgery and after I started to sit for extended time, not only severe pain bothered me, also a condition called Edema (excessive swelling of my right food). Both my doctors back then (until January of 2009), Dr. Cuff and Dr. Schulte knew about that additional condition.
Meanwhile I have developed more severe pain in the hip area of my operated hip, also of my left hip, back, and all the way up the neck. My severe and violent pain is causing me a lot of discomfort, my overall medical condition seems to get worst and worst, ie.
-I cannot get in and outside of a vehicle without terrible pain in my right leg and right hip.
-I cannot get up from sitting or laying down positions without terrible pain in my left and right leg and left and right hip.
-I can only walk very short distances without severe pain starting inside my right leg and right hip.
-I move and walk very slowly, because I am afraid to fall with every single step I do.
-I have to sit down in order to get dressed.
-When I turn my neck to the left or to the right a little faster than very slow, I see 'stars'. Also, when I move my neck, another violent pain stretches out all the way down to my lower back.
-Both my hands and arms developed a tingling sensation that stretches all the way from the tip of my pinky fingers to the ellbows.
-Each time I have to cough or sneeze, I experience a violent pain sensation inside right thigh and hip areas.
-I have Diarrhea almost all the time, no matter what I drink or eat. Many times there is also blood in my stool.
8. At the end of August 2010 I applied for Social Security Disability benefits. My initial claim was denied 11/23/2010. I am in the procedure to appeal that decision and report to the SSA that I am suffering from the DePuy hip replacement.
9. I am also in the procedure to seek legal help on the matter of my failing DePuy hip replacement.
10. At the present time, I believe that I am in urgent need of medical care. Having lost medical insurance due to the loss of my job, and being denied help from the local Senior Citizen Help Center, I am trying to gain eligibility for the County's Health Department.
11. While I have no complaints about Dr. Cuff's care and the care I received at the Venice Regional Hospital, I have a problem to see Dr. Cuff again. Reason why:
a) I cannot afford their fees as an uninsured person.
b) When you look up DePuy Orthopedics official website, and search for associated doctors in Venice/Florida, Dr. Noah pops up first. Dr. Noah and Dr. Cuff both work for Suncoast Orthopedics Medical Center, 836 Sunset Lake Blvd., Venice, Florida 34292.
12. Today, 12/14/2010, I filed a complaint with the FDA online.
Regards,
Juergen Schaberick
Venice, Florida
"How to find out if you have a recalled ASR hip implant:
Contact your orthopedic surgeon to find out if you received an ASR hip implant. Patients who do not know which surgeon performed their hip replacement surgery can ask their primary care physician or the hospital at which they underwent surgery to review their medical records for this information.
Patients in the United States who are still unable to determine the type of hip implant they received can fill out this release form and mail it to the address on the form. This will allow DePuy to contact your surgeon or hospital on your behalf."
tp://www.depuy.com/sites/default/files/DPY11Medical Release Form.pdf
Take care.....
HUGS
I wonder now if its metal poisioning. I dont know if the Depuy Summit is part of the recall. I have to get the model number from the hospital.
I shall pursue this further, probably through legal counsel.
I had my hip replacement in March of 2003, I received my hospial records and I have a AML/Pinnacle hip. Four years went by and I started having alot of trouble with my hip. First my hip locked up on me at work and swelling started in my hip, and severe pain started, I also have trouble walking, I walk with a cain now, life as I used to know it is no longer. It's hard for me to get through the days. My hip was popping and my Dr. did surgery and cut the tendions, no more popping but I still have the pain 24/7. I see a Pain Mgmt. Dr. now and have to take alot of medications and get shots in my back every 3 to 4 months. I thought I was alone in all of this but now, I see I'm not. What do we do!!!! I feel we need to join together and change what's happening.
We had our hips redone to try to have a better life but instead: We are all worse then before.(This is not right!) I would like to hear more and if you would like to contact me, my email is russuzeq@hughes.net God Bless
I have a really good lawyer on the case and Johnson and Johnson are pretty much bang to rights I'm told.
Now, as to my hip replacement difficulties; my surgery was on Mar. 17, 2010; I am experiencing many of the problems described by folks in these comments; i.e. pain, loss of leg length (which I find strange, since my surgeon had lengthened my femur during hip replacement surgery), and the inability to walk without a pronounced limp. The pain varies, at times subsiding to something bearable, leading me to believe I am recovering okay. Then, after a day or 2, the pain recurs and is intense. It is very discouraging; I have always been very active (a former runner, for one thing). I am going to visit my hospital to obtain my "operative report." For those who need to know how to find out what type of implant you have, see the comment posted by Kathleen Williams on 8/28/10. Thank you, Kathleen! I felt I was being dismissed by my doctor's office; they would tell me only that, though my implant is a DePuy, "it is not one on the list." There's no consolation in just knowing what it ISN'T; one needs to know what it IS! I found that the hospital records dept. will be happy to supply that info to me; I just need to show them a photo ID.
A word to "John Doe," who thinks seeking legal counsel is "greedy": Try to understand the apprehension, the fear, & the hopeless agony folks are suffering--young people who have lost jobs & med. ins. coverage, who have no way to pay for more surgery--Where the hell are they to go for restitution??? Shall they perhaps get foreclosure on their homes? Yes, we can be a litigious society; lawyers do get rich. But, John Doe, whoever you really are, bear in mind that the vastly wealthy corporations that cause the otherwise defenseless population such agony can and must pay--and lawyers are the folks who can make that happen. Oh, and "Sad Son" should also look into legal redress; he deserves at least that much.
I was amused that someone who obviously suffered a great deal said "it almost makes [him] angry." Almost angry??? I'm far past almost.
I do want to state that I have found my surgeon to be a very competent, compassionate person. In no way do I hold him responsible for J&J/ DePuy's irresponsible, reprehensible conduct. My problems may not be due to an inferior, recalled implant; perhaps I have other complications. That will be determined by further investigation. I, however, want someone "in my corner." Thus, I have contacted a legal firm. I have more physical pain than I ever anticipated for far longer than I expected, compounded by the fear that something very hideous and formidable may be about to occur to me.
The very best of luck to all out there who are struggling with this problem!
1. My right hip was replaced using one of the DePuy devices 2 days before Christmas 2008.
2. For the first 3 months after surgery I was unable to lie down straight in bed, only changing certain positions hourly sitting in a recliner allowed me to bear severe and violent pain.
3. Once I was ordered to walk on full weight, I was never able to walk more than half a mile without severe pain kicking in. Actually, to the day my hip replaced leg starts hurting badly when I walk only very short distances. Now, almost 2 years after surgery, many times severe pain kicks in when I just sit or lie down.
My surgeon always suggested to be patient as recovery from a severe operation like that could take up to a year.
4. The last time I saw my surgeon was a little over one year post-surgery. Again, I told him how severe my pains still were.
5. During this past spring/summer I tried to see my surgeon again. Mainly because I was suffering more and more. Unfortunately, due to my long tern ‘Leave of Absence’ I had lost my job and all my benefits including health insurance. My surgeon’s front office told me over the phone that I would have to pay a fee of $160 just to see the doctor as an uninsured person. I thought that that was odd because my surgeon and office knew that I never had recovered from all the post-op pains.
6. Just a short time ago I learned about the recalls and class-action lawsuits on the DePuy devices. Well, it took 4 phone calls and leaving messages with my surgeon’s office. Now, they finally returned my 4th call, and informed me that my hip replacement is a DuPuy device. Not without to mention that my hip replacement might not a DePuy device under the recall……Can you imagine a statement like that? To a patient who cannot sleep for more than an hour at a time because of severe pain in the area where hip was replaced?
After that statement of my surgeon’s office, I am not just questioning the possibly illegal $114 million in kick backs to surgeons, furthermore I am questioning if surgeons are still paid by DePuy Orthopedics. Now, only to put up a ‘first line of defense’ against patients so they don’t participate in law suits.
Worst comes worst:
I was told that DePuy is trying to get patients to sign medical release papers from hospitals. Supposedly, they claim that they would examine their bad devices. But I have also heard that investigators found out already that DePuy is destroying these devices in fact. All in order to get rid of evidence needed for class action law suits and upcoming trials.
My personal situation and circumstances make me almost angry. I apologize for that, but meanwhile and gathering a lot of information, who knows whether it is just DePuy hip replacements on recall, or is it all of their hip replacement devices? My severe pain is constant and severe. It is no fun to be unable to sleep for more than a couple of hours at a time, and that since almost 2 years. Having lost job, health insurance, and all the other benefits crippled me to a point that I had to file for disability.
Will there be justice done to victims one day?
Regards,
Juergen Schaberick
A car wreck involving a head on collision left me with a broken left hip. The hospital stay was for 3 months until recovery. In September 1991 I had Hip Surgery at Galveston Medical Center. The hip was supposed to last from 10 to 15 years before needing another depending on how much the hip was used. I started working at Motorola in January 1992 and became a full time employee by October. The hip didn’t hurt but the doctor said I still had a small limp because I was accustomed to limping for 5 years. It took me three years before the limp went away and I walked normally. I could trot but not run and I could also play volleyball. While I was walking in Motorola I would look at myself on the window reflection to see if I still limped. I could walk normally and couldn’t see any limp while I walked.
2002
I began to have pain and began limping a little so I decided to ask for advice a Doctor in Sequin. He x-rayed my hip and did some tests then told me I had worn out the hip socket and it was causing the pain. He talked me into 40 year hip and he scheduled me to have it done in the last week of November. I was operated on and went home after 3 days.
2003
I asked him if I should still be limping and he said in time it should go away. I kept going back to him every other month or so for check ups because the pain was still there.
2004
. I couldn’t stand for long periods of time and I couldn’t bend and lift. I was always hurting myself easily and a sitting down job was all that I would be able to hold. I had scheduled with the Seguin Dr. because I was upset with my condition and knew something was wrong. He checked me and said that I was as good as I was going to be. He said the hip was showing nothing wrong in the x-ray and it was coming along fine. I disagreed with him because I was in pain every time I took a step.
I also told him my bones or something in my leg kept popping like when you crack your knuckles. I didn’t want to know how good the operation looked I wanted to know why I was in such pain! I asked for a second opinion and the Seguin Doctor said if I wanted to get a second opinion he wouldn’t be offended. He set me up with a Doctor in San Antonio who was also a UT professor on August 31,2004.
Went to San Antonio to see this Dr in October and explained my situation then after a few visits he diagnosed the hip was too short and I needed a longer stem so he suggested he replace it with another. Not knowing any better I agreed to it confiding in his opinion so we scheduled an operation on December 1st 2004. I was released after 4 days and went home. I used crutches and then a cane until I began walking. I complained to the Dr. that I was still having pain a few months later so he took several x-rays and said the hip was doing fine but it just needed time to heal.
In Feb. 2007 I noticed my hip was weak at some points and it was clicking and making noise. I still had a lot of pain and limped badly with it. My hip began popping out and I would lose all strength to my left leg when it did causing me to fall at times. The only way to regain my strength in it was to pop it back in. I also realized my leg was shorter then the other. I went back to the Seguin Dr and got revaluated and he said everything looked fine and the only thing it may be was a defective hip. He said he wanted to get more tests and he stuck a needle into my hip and pulled out some fluid that he said he was going to have analyzed. On my next visit he said my hip was infected and had to be replaced. This would require that the hip be taken out and nothing replacing it for 6 weeks but antibiotics then, reinstalling the new hip which means 3 months of rehabilitation.
In 2009 they let me go from my job and I filed for disability and in Jan. 2010 they sent me to a doctor and gave me my disability. I am now at home and disabled because my leg goes out at unusual times and if not careful I will lose all strength and fall. I can’t ride a bike or anything except my car and no exercised pertaining to my leg. I can’t play with my grandson like I would like so I’m very unhappy. I finally got set up with a doctor in Austin who was recommended by personal family doctor. He was familiar with sports injuries and specialized in orthopedics. He did 3 extensive tests to find out how much infection my hip had and he came back with good news. My hip was not infected but I did have a defective hip which had to be replaced. We arranged to have this done this November 10 in Austin. I feel like the other doctors were unable to admit they may have had something to do with the bad implantation. I contacted the Dr in San Antonio and he said my Johnson and Johnson Depoy hip was not one of the recalled ones. I disagree since the similarities are the same so now what do I do?
Just last week the surgeon told me to stop all exercise, all PT, limit my walking to getting to work and home, and stay off my legs. He wants me to wait two months before we look at it again.
Right now all signs point to a need for a revision which concerns me.
I'm wondering how different the Pinnacle system is from the recalled ASR system. I wish they would publish the statistics on these things so people can make informed decisions on the type of implant rather than relying on a surgeon who has royalty payment incentives to go with one implant over another.
Also I noticed that some people are questioning the reimbursement plan that DePuy intends to use. I found the following on DePuy's website for patients affected by this particular recall. "Bills for services should first be submitted to your insurance company or payor (public or private) in the usual manner. DePuy will then reimburse you for your reasonable out of pocket expenses and your insurance company or payor (public or private) for customary and reasonable expenses related to the ASR recall." I think what this means is that we should submit the charges to our insurance company and either also send DuPuy a copy of the charges, let our insurance companies know about the situation, and send a copy of the bill to DePuy. I admit this is a pretty complicated way to handle this, but it may be the customary way to handle in such situations. Only an attorney would know for sure, but I think it is our responsibility to make sure that our doctors, hospitals, and insurance companies AND most importantly WE are not ripped off.
Mark and his wife Frances, my sister, have asked me to represent them in a lawsuit against DePuy. They want to recover damages for Mark's severe pain, medical bills for the 3 surgeries Mark had to have because of the defective hip. And, the defective hip resulted in Mark having to undergo that second operation, the one where the surgeon had trouble getting the DePuy part out because it has loosened and migrated. The drop foot followed that surgery and is clearly related to the defectiv implant.
I am writing to ask that if anyone posting on this site has a DePuy Pinnacle please contact me or if you have a lawyer have that lawyer contact me. I am trying to gather information and complaints by those who have experienced problems with the Pinnacle implant. I would like to have a database showing a certain number of people who have experienced problems with the Pinnacle in the likelihood I need that information to help prove my brother-in-law and sister's case. This information showing numerous problems with the Pinnacle may lead to an investigation into whether the Pinnacle should be recalled.
Please, if you've had a Pinnacle implanted and you are having problems with it contact me so that you can compare notes with Mark and his wife. Products Liability cases can be very diffficult because manufacturers fight back hard. In these hip implant cases, the manufacturer is probably going to try and avoid liability by blaming the surgeons.
If you are agreeable to comparing notes on your Pinnacle implant please contact me by phone--504 482-5432 or 504 524-4407 or email- garloo@cox,net
Thanks for your reading this and for any information you may provide. To be clear, this is not a solicitation for cases. I'm only interested in hearing about the experiences others have had with the Pinnacle insofar as it may have an impact on my family's case.
I just found out (from the surgery scheduler) that my surgeon uses De Puy. or at least has been. I have not asked him about it as of yet. i will be getting the metal cup with the new plastic liner and a ceramic head.
Has anyone had this type of apparatus implanted and if so how is it going? Good? Bad? I want my life back. i train and show my dogs and want to start doing that again.
I am a Chiropractor so my doc is going to get grilled like a cheese sandwhich. I speak his language so unless he outright lies to me he won't be able to over talk me.
Thanks,
I had the pinnacle 3/30/10 put in my right leg and 2 months after I started losing the pigment in my skin....anyone had this happen after their replacement. My replacement clicks all the time, is this common here?
Hello Barb.I had a THR @ age 48 in 2008. Mine is also the pinnacle/metal to metal implant.I too have had the clicking and clunking almost since day one.I recently went to my Dr,He has noted a chan ge in my x-ray since last year.I was told that i have bone reabsorption. The clicking does not hurt but sometimes it does seem to become stuck for a moment.I dont know If I am up to another surgery and recovery.I now go every 6 months for an x-ray.Guess I will figure out what to do come april>
Now yesterday I got this letter in the mail announcing the recall.
Now I am fearful of what may happen. I have some aches and pains, but it was much less than before the surgery so I haven't complained. But now I am ewondering if everything is ok with the replacement.
Anterior hip replacement - if you need one check this one out.
Ken...
Go to the link to the Depuy website. The years are 2003-present so you're in the window.
Ken Snyder...
By all means, get a second opinion. IF you are not in pain, the only thing you might risk by waiting is that perhaps an easier "resurfacing" operation could be done. I think may of us here had our hip(s) done because of the extreme pain we were already in. Find out from both Dr.s what their opinion on waiting is and why.
My surgeon put me through all kinds of tests and could not figure out what was wrong. I was referred to another Dr. that had me take a specialized blood test that showed that I was allergic to nickel and iron. Since I had a metal implant it was obvious why I had pain. Over the year, the pain as increased and my socket is loose in the hip. I will eventually have to have a revision surgery and replace the metal with ceramic. I have done that already on my left hip this August and so far it feels better but it has only been a few months. I guess only time will tell. For those who want to follow up with that specialized blood test, I am posting the website: www.orthopedicanalysis.com. It cost $500 and my insurance did not cover it but it was worth it to finally find out what was wrong.
You'll be glad to know that the Arthritis Foundation is very supportive of the creation of patient registries to advance scientific discovery and clinical care.
Patience White, MD, our vice president of public health, sits on the board of the American Joint Replacement Registry, a national, non-profit initiative. You can read more by going to this website:
http://orthodoc.aaos.org/ajrr/grp_index.cfm
Additionally, the Arthritis Foundation has just launched the Arthritis Internet Registry, or AIR, which will track the outcomes of people with rheumatoid arthritis and osteoarthritis. You can read more about AIR here:
http://www.arthritistoday.org/news/arthritis-internet-registry.php
And we've been a major partner in the creation of the Consolidated Pediatric Rheumatology Observational Registry, to track the fates of children with Juvenile Arthritis:
http://www.arthritis.org/murphy-remarks.php
Kind regards,
The Editors
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IMHO, whenever a doctod PUSHES a procedure, be very wary, and if the pressure continues, DO GET a second opinion!
As to possible harm from delay - not really. If the problem is due to cartilege degeneration or missing, you will eventually have more erosion of the socket, but that will be replaced as part of the procedure anyway. If you arfe indeed pain free, be thankful, and do not respond to the doctors pressure. Also ask the second opinion doctor about root cause and possible damage if you delay - hopefully you'll get a straight answer.
(The Right side is becoming a bit troublesome, but without knowing the brand, it's hard to tell if it may be the appliance or another cause.)
Oh - and now I'm on Medicare - & don't know if Medicare really cares sbout the entire scenario or not...
(Yet more compelling reasons to have a worldwide registry...!!)
I believe a class action suit needs to be brought against Depuy for this product they knew was failing but continued selling it to doctors. I think a suit with all costs paid plus damages for lost work and wages and mental and physical agony should be given to people who have to have these things replaced.
Their offer of just paying out of pocket costs after your insurance company pays is BS.
I also think that all who expressed concerns about pain or other problems need to see their surgeons asap. There is no need for any of us to have to suffer like this over a defective product from Depuy. They are thinking they are going to get off easy. I don't think so. A suit is bound to become reality.
After going to the "click here" sit mentioned in the following sentence in this article:
"For more information, including instructions on how to find out if you have an ASR implant, click here to go to the ASR recall web site."
gives a lot of info and tells you to call your surgeon directly. There is also a statement about reimbursement of revision surgery if you need it done that Depuy will pay out of pocket costs after your insurance company has paid its' part. I wonder what happens if your insurance company refuses to pay for the revision surgery if you need it.
That is somewhat of a concern for me since I have only Medicare. I have the feeling the revision surgery would be denied.
Anyone have any info on that?
Also my surgeon's office said they just got the information today on the recall and have not figured out yet how they will be handling this issue. They are going to call me back they told me.
Australia, unlike the U.S. has a joint replacement registry, which allowed the malfunction of this prosthesis to be tracked and recalled.
The Arthritis Foundation should be lobbying for the establishment of registry, which all developed countries except the U.S. have.
The piece was just cleaned and not replaced. What would this mean for her now?
Either some of you have not really listened to your surgeon or you may have not found a really good one. THANKing the Good Lord and my surgeon EVERYDAY for the miracle of replacement hips
The implant name, type, serial or other identification number, lot number, etc. will be documented on the operative report and any "complications" of surgery that you may not have been notified about.
(I transcribe medical reports.)
at Cottage Hospital that does hip replacements. He is the best in the country. People rave about him and people all over the world come to Cottage Hospital.
I would be happy to give you the information if you e-mail me. I had one hip replaced last year. No problems and am fully recovered.
Dale (Ms.)
then decembr 2002, I was expierencing severe pain whenver I walked. Felt like the rod was slamming into the bone with each step, especially if there was a dip in the sidewalk or ground area. My own orthropaedic surgeon was unable to find anything wrong even did a complete bone scan and nothing showed. Finaly I decided to get another opinion at a Boston Hspital and found that I did infact needed a revision surgery done. So after alomost 2 years in severe constant pain, I did go through the revision surgery in October of 2004. Then five years later, had the right total hip done. Now my right side down the thigh has been quite painful especially when I wake in the morning and when I sit. I will be going to my first year checkup in december, should I inform my doctor of this recall on parts or is there something else that is wrong.
constant pain while walking for the following year. My surgeon ask me to give it more time. I gave it another year and ask if something could be done, I was still in pain. The surgeon replaced the part that was in the leg bone. The result was,
little or no pain while walking, but painful if I run. I have not yet been able to talk to my surgeon or anyone in his office.
I have no clue who the manufacturer of my replacement is. I had to give up Tennis and spike sports entirely. I am not a happy camper.
I don't know what I should do. Any suggestions?
What ticks me off the most about this is the company is only offering to cover "reasonable & customary expenses" involved in this recall. BS!!! I called a high powered attorney today and they are looking into a lawsuit. The whole point in him getting this hip was he is so young and he would never have to have it done again. Now we are talking about 25 years worth of lost wages, future social security earnings impacted, retirement savings lost, potential issues with medical bills not being covered by insurance, pain & suffering and the potential that he could end up never walking again. They can't just cut the bone off again to remove the shaft. What if he ends up in a wheelchair to never walk again. No matter what age you are this is awful but at age 42 this is life altering and a VERY BIG DEAL!!!!
Here's wishing the best for those who are more likely to need a revision.
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