DePuy ASR Metal Hip Replacement Linked to High Failure Rate
Published: March 12th, 2010 • Comments: 12
DePuy Orthopaedics, a division of Johnson & Johnson, has indicated that its ASR metal-on-metal hip replacement system, has been linked to a high failure rate and the device will be removed from the market.
While the company initially indicated that the DePuy ASR hip cup was being phased out due to low sales numbers, a letter was sent to doctors on March 6 warning about a potential risk of ASR hip replacement problems. Many patients have experienced hip failures soon after the device was implanted, leading to an additional expensive and painful hip replacement surgery.
According to a report by the New York Times, some medical experts have said that a DePuy ASR cup recall should have been issued earlier, claiming that the failures are linked to a design problem that makes them difficult to implant.
DePuy officials say that ASR hip implant failures are most likely to occur in patients of smaller stature, including women and individuals with weak bones. The FDA has received complaints from about 300 recipients since 2008, most of whom had to undergo another round of hip surgery to replace the defective ASR hip implants.
The ASR is a metal-on-metal hip replacement system. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.
Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris. Surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip implant problems, and possibly need to have the devices replaced, due to metallic debris.
DePuy announced it would phase the devices out by late 2010. However, the hip implants have already been put into thousands of people’s bodies worldwide. DePuy said the withdrawal was not caused by the problems, saying that the failure rate was new information.
All of the major orthopedic medical device companies manufacture their own version of “metal on metal” hip implants, and several have said that the metallic debris problem does not pose a significant risk. However, an increasing number of orthopaedic surgeons and experts disagree. In a recent editorial in the Journal of Arthroplasty, the medical journal warned doctors to avoid the use of the metal hip implants, and said they should only be used “with great caution.”
As a result of the increased reports of problems, product liability lawyers are investigating and reviewing potential DePuy ASR metal hip replacement lawsuits for individuals who received the device and experienced complications, including hip replacement failure or other hip problems.
Comment by Sherry on 14 March 2010:
My sister had the De Puy ASR hip replacement device put in her hips 3 years ago. In December, ‘09 she had to have the one replaced due to pain, limping and various complications. Much metalic debris was found, and a brownish fluid developed in both hips. She will need to have her other hip redone also. There are numerous concerns–h present health and her future!
Comment by J. Sargent on 21 March 2010:
Failure of total hip replacement in less than 9 months. DuPuy metal on metal components were used. Revision and removal of all components by the Mayo Clinic 14 months later.
Comment by Ann on 29 March 2010:
Failure of total hip replacement 7months later – metal on metal components used. Planning revision surgery now.
Comment by Chuck on 29 April 2010:
on 10/22/08 at the age of 48, I had the De Puy device put into my right hip. By late February of 2009 I started telling my surgeon something didn’t feel right. I complained for the next 9 months as discomfort tuned into pain & i was actually in need of a cane to walk some days. My surgeon would take an xray & state, it’s placement is fine. In November my hip swelled out baseball size. In short, I justhad second much more painful replacement, at the amazing Johns Hopkins Hosp. It was done 3/23/10. I am recovering very slowly.
Comment by jackie on 3 May 2010:
I had bilateral hip replacements 2 and 3 years ago. I have continued pain bilaterally (worse than preoperatively ) and cannot put full weight on one. Doctor tells me there’s nothing wrong.
Comment by Gerry on 9 May 2010:
I had a Dupuy metal-on-metal hip implant put in on 4-11-2006. About a 2 yrs after I started having pain whereby I couldnt sit for long, then at work while at a meeting…the implant became locked out of place where I couldnt move…..I tried to move slightly and it snapped back. I immediately called my surgeon who took xrays the next day and he said it was ok…and not to worry. But, I kept gettting pain since then and finally just 2 weeks ago, on April 25,2010, while sitting at a festival, it became completely dislocated. I could not move, was in extreme pain, and had to be taken by ambulance to the hospital emergency room where I remained for 3 hrs. until they finally re-set it under morphine… I’ve been back to my surgeon for a flouroscopy xray where he took excess fluid and blood out from around the implant and he showed me some chips that had been off the implant. also he gave me a shot of cortizone. he indicated I would need to have this upper cup part removed and replaced as soon as possible, and I have been calling and waiting for a return call to schedule the surgery, and and not getting a call back….I have been out of work for 2 weeks due to the constant pain and don’t know even if I am getting paid for my loss of time from work. Also, my doctor/surgeon said it could pop out again at any time. I feel like a walking time bomb.
Comment by Fanny on 15 May 2010:
I had a replacment Oct 2008 I have been in I had notting but Problems. My hip clicks when I walk. The dr says its OK he sent me all sorts of test MRI BONE SCAN and still he says its OK He thinks its from my back BULL. I pay Co Pay for needless Diagnostic test. He says it coming from soft tissue . Everytime I go to see him for a follow up I have to pay for the co pay. I can[t sit for long I can[t put presure I have a lot of pain I am A hairdresser I need to work I don[t know for how long
Comment by parrish on 19 May 2010:
im 50 yrsold i have had 3 hip replacements from the age 29 until now .two of my hip replacements have failed and there is very much pain the first one loosened down in the bone and so did the second one this time with bone lost. my third one i had a bone graph done and with a longer replacement after that the rotating cup removed.but by the time news comes out about recalls .the stature of limitations runs out. we cant blame the docs for what a company makes so there should not be limtations on class actoin law suits all people want is to not be in pain. is ther someone that can help change the stature limitations laws on medical devices because docs did not produce the product companies are at fault .it makes it diffuclt to have turst in doc when they use defective parts.i also read that alot of people backed out of their claims could it be because of what i have experinced about the stature of LIMITIONS. THIS REALLY NEEDS TO BE ADDRESSED . BECAUSE THIS IS A PROBLEM.
Comment by Diana on 13 June 2010:
I had a left hip replaced with DuPuy metal components in Feb 2007. It collapsed after ten weeks, a subluxation, as it ‘went back’ after 20 minutes of sheer agony. At the time of the THR my trochanter was broken accidentally. I was in continual pain and the two cerclage wires which were said to be causing inflammation were removed in August 2007. My iliopsoas muscle was also cut to elongate it. In Oct 2008 I had an ultrasound scan and a steroid injection but the trochanter had not united. The radiographer said my pain could be caused by debris. A bone scan in Feb 2009 showed the THR to be loose and in July 2009 I had a hip revision, the two cerclage wires replaced – but one came apart during that week. In March 2010 I had another untrasound scan and another injection with little or no effect on the pain. I am now awaiting a fourth operation to have the wires removed or fixed and another muscle elongated. Today I read in the Sunday Express that DuPuy metal components may be causing severe problems and you can imagine I am very concerned. UK patient, June 2010.
Comment by Victor on 30 June 2010:
Age: 58 Dec. 2001 fell 16′ off roof, landing on my feet. Nov. 2002 due to left knee pain. Have had a total of 6 surgeries on the left knee. 3 left knee replacements. I will come back to the knee later.
7/10/2009 I was washing the windows at home. My ladder tipped over and I fell 3′ shattering my left hip. 7/11/2009 had hip replaced. Had no pain after the surgery. About 6 weeks later started having thigh pain. Dr. said it was stem pain. Began having severe hip pain, then groin pain.
Each day was worse than the day before. Dr. could not tell me what was going on. He kept sending for therapy. Making it get worse. The therapist said something is wrong. Had metal allergy testing done. Guess what. I was very allergic to the Cobalt. Dr. referred me to Swedish Hospital before I had the test results back. Took those to the new Dr. Had a Cobalt Serum blood test. Yes I was still very allergic to the Cobalt. I told the new Dr. that I was in a living hell. I begged him to help me. Having replacement surgery on 7/12/2010.
Back to the knee. The Dr. who put both knee and hip in called me the evening I had met with the Dr. at Swedish. We talked for 20 minutes or so. He says to me, now that explains the pain in your knee, ( after over 2 years of pain.) there is Cobalt in the knee he put in.
I do not even know how to react to all of this, having had one ortho surgeon tell me to see a shrink. After a lot of research, I find I am not the only crazy person with this problem. What is even more strange is the FAA has a list of materials that are banned from aircraft because of the hazard to humans. Guess which one it is. Cobalt. I am hoping to find the end of the problem. I am very scared as to what the out come may be.
Comment by Shirley on 4 July 2010:
I had my right hip replaced March 2009, my leg had been elongated by 3cm during the surgery and I was in agony. A registrar had done the surgery and not the consultant as I had expected. I had revision surgery in June 2009 which did correct the leg length discrepancy & after a very slow recovery period I started to walk better & managed without a stick, this was only for a short time and now I am suffering extreme pain & finding it very difficult to weight bear. An ultra sound scan has shown fluid build up in and around the joint, I’ve had a nuclear scan(waiting for the results ) and I’m due to have a MRI scan soon despite having a steel cage spinal fusion. I have an appointment at the end of this month to see a consultant & I pray that he will be able to do something to help me very soon as it’s difficult to cope the way I am. Shirley UK patient.
Comment by Derrick on 23 July 2010:
Had a hip replacement in December 2009 and it failed and now having another one in August 2010. A very big inconvienience, cost and the pain.