DePuy Recalls Custom Hip, Knee Replacement Implants at FDA Request

DePuy Orthopaedics, a division of Johnson & Johnson, is recalling all of its unused custom orthopedic implants, following concerns expressed by federal regulators that the devices never underwent any sort of review or scrutiny. 

DePuy recalled unused custom hip and knee replacement implants last week, months after the company shut down a division of its orthopedic implant business that sold custom devices made for specific patients’ anatomies.

In January 2012, it was reported that FDA warned DePuy about problems with the sale of the custom knee and hip replacement implants without obtaining approval to assure that they are safe and effective. FDA inspectors said not only were the devices sold under the radar, but they were also made with poor quality control procedures.

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“Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured,” said the FDA in a warning letter sent on December 8, 2011. “The fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”

The FDA forced DePuy to remove 14 different implant components from the market following that warning letter, until the issue could be resolved. However, DePuy decided to shut down the division and this week a DePuy recall was issued for all of its unused custom implants.

It is unclear how many devices are being recalled, as DePuy is not releasing the number. However, the medical device manufacturer has previously indicated that more than 8,300 of the custom implants have been sold since 1999.

DePuy has faced a number of problems with hip replacement components in recent years, primarily involving metal-on-metal configurations that have been shown to shed metallic debris as the metal parts rub against each other. This has resulted in more than 8,000 lawsuits over DePuy ASR hip implants and nearly 2,000 lawsuits over DePuy Pinnacle hip implants.

A DePuy ASR recall was issued in August 2010, after the company acknowledged that the system was associated with a higher-than-expected failure rate, with many patients requiring revision surgery within a few years to remove or revise the hip implant.

7 Comments

  • DonaldFebruary 22, 2017 at 3:37 pm

    I to had a Depuy sigma total knee implant and from day one I had blisters all over my knee. I also saved the pictures. I have so much pain and suffering from it giving out, stiff can't walk up or down stairs like a normal person, can't find a comfortable position rather it be crossing my legs laying on my stomach or sitting. I tried many times to talk with the surgeon but to know avail I tried goi[Show More]I to had a Depuy sigma total knee implant and from day one I had blisters all over my knee. I also saved the pictures. I have so much pain and suffering from it giving out, stiff can't walk up or down stairs like a normal person, can't find a comfortable position rather it be crossing my legs laying on my stomach or sitting. I tried many times to talk with the surgeon but to know avail I tried going to the emergency room I tried calling the manufacture I even went to a doctor outside of my State. I now am dealing with a Patella Baja. It will not move like its supposed too. I have called every lawyer that would listen but can't find anyone that cares. I wonder what they expect people that have a implant that doesn't perform the way it was designed to. I do pray that this touches someone who cares enough to help make life a little more bearable.

  • bridgetApril 24, 2014 at 5:27 am

    I had a total left knee replacement in Feb 2012 try match by Aug I was experiencing extreme pain swelling found out it had loosened. Under went revision in in Nov 2012. Has anyone else had problems. Is there an attor ney who will help me

  • SusanFebruary 16, 2014 at 9:29 pm

    Comment by SUE on 7 December 2013: I to had left knee replacement with Sigma Depuy rotating platform in June 2011. In May of 2012 I started having extreme pain in my femur right above the knee replacement this went on for a couple of days this started on a Thurs I could only stand or walk on it for just a few min without having severe pain on Sun I was walking my shoe sunk a tad in ground it had [Show More]Comment by SUE on 7 December 2013: I to had left knee replacement with Sigma Depuy rotating platform in June 2011. In May of 2012 I started having extreme pain in my femur right above the knee replacement this went on for a couple of days this started on a Thurs I could only stand or walk on it for just a few min without having severe pain on Sun I was walking my shoe sunk a tad in ground it had rained and ground was soft I tired to pull my foot up and fell tried to stand but could not get up went to emergency and found out that the femur broke right where the knee was attached this is the one and only bone I have ever broke in my life I was 52 when this happened .I had to have surgery my leg was cut on side huge incision plate and screws were put in to assure the fracture healed correctly my femur healed was in a wheel chair for 2 months was not allowed to walk on it my femur healed but had continous pain and swelling in my calf, ankle and foot couldn’t even see my ankle bones. I kept going back to my Surgeon with concerns that something was wrong every time I went he would x-ray me and say nothing was wrong. Finally after months of going back with same complaint he decided to remove plate and screws he figured they were irrating the knee and that would stop swelling had that done in March 2013 at time of surgery I asked him to please scope my knee since he had to once again cut my leg wide open to remove plate and screws which I have .He flat out refused and said absolutely not because once the x-ray showed the knee looked fine and there was nothing wrong with the knee. After the plate was removed and I healed I continued to have pain and swelling nothing had changed .I went back again several times with concerns that something was still not right he refused to do any testing etc. other than x-ray and tell me it was fine, that the snapping ,popping, swelling etc. and deformity of my knee was all normal. I then decided I needed to get another opinion which I got 3 and was told by all that the knee appeared to be loose 2 surgeons said they would send my surgeon a note with there opinions. I finally found a surgeon who listen to me and did a lot of extensive testing radioactive scan ,blood ,Ct rotational scan etc. .Through this process we found that the patella was up under my femur and it appeared that it did not even fit my knee and looked as if it the cut was wrong .He suggested we do a arthroscopic surgery to do a lateral release to get the knee cap back in place .I had the Surgery on Nov 7,2013 while doing the surgery he found my meniscus was torn and was shocked at the amount of scar tissue that was and is still in my knee he explained after that with the scope there was no way he could remove the tissue on the sides of my knee so its possible we may have to go back in to remove the scar tissues on the sides he is hopefully that enough was removed so that I won’t have to go through another huge surgery where my whole knee will have to be cut wide open,also told me that the patella may not stay in place either He gave me a video of the surgery on Cd which I have .So glad I found a great surgeon and he will continue to be my knee doc. This has been a nightmare for me. I truly believe this is all from the knee replacement and feel that some course of action needs to be taken .I have lost my home to foreclosure etc. as I am not able to work and am know on SSDI.Any comments or suggestions would be appreciated if you are not interested in taking my case. .Sorry I didn’t mean to write a book but felt my story needs to be heard and some course of action taken.

  • josephJanuary 8, 2014 at 7:57 pm

    I had a Depuy bi lateral knee implants done in May 2011 (Dr Nevulis withe Norristown Orthopaedics), pain swelling and premature loosening and clicking for months after operation, I had to have total revision of left knee ten months later march 2012. one year later still in pain ,swelling I had to have the right knee revised march 2013 this time by a Dr Lee with Penn medicine, and the most recent[Show More]I had a Depuy bi lateral knee implants done in May 2011 (Dr Nevulis withe Norristown Orthopaedics), pain swelling and premature loosening and clicking for months after operation, I had to have total revision of left knee ten months later march 2012. one year later still in pain ,swelling I had to have the right knee revised march 2013 this time by a Dr Lee with Penn medicine, and the most recently the left one revised on November 26, 2013. Still having having knee pain and swelling . My left knee replaced three times and right knee replaced two times --all in two and a half years. I need a lawyer to sue Depuy , lost my job and significant income. Lawyers I have been in contact with won't take the case because of time and money, also saying it may be hard to prove product liability. Is there, ANY ATTORNEY OUT THERE INTERESTED!! -

  • SUEDecember 7, 2013 at 10:05 am

    I to had left knee replacement with Sigma Depuy rotating platform in June 2011. In May of 2012 I started having extreme pain in my femur right above the knee replacement this went on for a couple of days this started on a Thurs I could only stand or walk on it for just a few min without having severe pain on Sun I was walking my shoe sunk a tad in ground it had rained and ground was soft I tire[Show More]I to had left knee replacement with Sigma Depuy rotating platform in June 2011. In May of 2012 I started having extreme pain in my femur right above the knee replacement this went on for a couple of days this started on a Thurs I could only stand or walk on it for just a few min without having severe pain on Sun I was walking my shoe sunk a tad in ground it had rained and ground was soft I tired to pull my foot up and fell tried to stand but could not get up went to emergency and found out that the femur broke right where the knee was attached this is the one and only bone I have ever broke in my life I was 52 when this happened .I had to have surgery my leg was cut on side huge incision plate and screws were put in to assure the fracture healed correctly my femur healed was in a wheel chair for 2 months was not allowed to walk on it my femur healed but had continous pain and swelling in my calf, ankle and foot couldn't even see my ankle bones. I kept going back to my Surgeon with concerns that something was wrong every time I went he would x-ray me and say nothing was wrong. Finally after months of going back with same complaint he decided to remove plate and screws he figured they were irrating the knee and that would stop swelling had that done in March 2013 at time of surgery I asked him to please scope my knee since he had to once again cut my leg wide open to remove plate and screws which I have .He flat out refused and said absolutely not because once the x-ray showed the knee looked fine and there was nothing wrong with the knee. After the plate was removed and I healed I continued to have pain and swelling nothing had changed .I went back again several times with concerns that something was still not right he refused to do any testing etc. other than x-ray and tell me it was fine, that the snapping ,popping, swelling etc. and deformity of my knee was all normal. I then decided I needed to get another opinion which I got 3 and was told by all that the knee appeared to be loose 2 surgeons said they would send my surgeon a note with there opinions. I finally found a surgeon who listen to me and did a lot of extensive testing radioactive scan ,blood ,Ct rotational scan etc. .Through this process we found that the patella was up under my femur and it appeared that it did not even fit my knee and looked as if it the cut was wrong .He suggested we do a arthroscopic surgery to do a lateral release to get the knee cap back in place .I had the Surgery on Nov 7,2013 while doing the surgery he found my meniscus was torn and was shocked at the amount of scar tissue that was and is still in my knee he explained after that with the scope there was no way he could remove the tissue on the sides of my knee so its possible we may have to go back in to remove the scar tissues on the sides he is hopefully that enough was removed so that I won't have to go through another huge surgery where my whole knee will have to be cut wide open,also told me that the patella may not stay in place either He gave me a video of the surgery on Cd which I have .So glad I found a great surgeon and he will continue to be my knee doc. This has been a nightmare for me. I truly believe this is all from the knee replacement and feel that some course of action needs to be taken .I have lost my home to foreclosure etc. as I am not able to work and am know on SSDI.Any comments or suggestions would be appreciated if you are not interested in taking my case. .Sorry I didn't mean to write a book but felt my story needs to be heard and some course of action taken.

  • LarrySeptember 14, 2013 at 8:30 am

    I had a Depuy knee implant done in March 2009 , pain swelling and blisters for months after operation, have photos saved. Two years still in pain ,swelling and found out that I have nickle poisoning from implant. In 2011 , had to have gallbladder removed it failed , still having having knee pain and swelling can\\\'t walk. Went to new knee doctor in 2012 my doctor left state, found out needed re[Show More]I had a Depuy knee implant done in March 2009 , pain swelling and blisters for months after operation, have photos saved. Two years still in pain ,swelling and found out that I have nickle poisoning from implant. In 2011 , had to have gallbladder removed it failed , still having having knee pain and swelling can\\\'t walk. Went to new knee doctor in 2012 my doctor left state, found out needed revision of knee and not only did I have nickle poison but I also had a double bacterial infection in the knee fluid and my blood, Had knee removed for twelve in wheelchair and needed IV twice a day of the strongest antibiotics for infections foe six weeks. In 2012 revision ,new knee,short lived ten months , in 2013 hah to have second revision, third total knee replacement. Waiting and hoping this one will work after four operations in four years. Trying to find a lawyer to sue Depuy , lost so much, but they say it\\\'s approved by FDA and won\\\'t take the case, ANY ATTORNEY OUT THERE INTERESTED!! l

  • Jo AnnAugust 24, 2013 at 10:50 pm

    I had a knee replaced in March, 2009 with DePuy \\\"The Sigma RP-F Knee .\\\" I have had problems from the beginning with a \\\" clicking noise\\\" when I walk. Knee is always swollen and sore. My Dr.says nothing can be done with that knee. Walking is a problem, also.

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