DePuy ASR Recall Issued After Warning About Hip Replacement Failures
The market withdrawal of the DePuy ASR hip replacement system earlier this year, combined with a warning to physicians about the high failure rate associated with the device, are now being called a DePuy ASR recall by the FDA.
The FDA indicated on July 17 that the actions of DePuy Orthopaedics, a subsidiary of Johnson and Johnson, in regards to its ASR hip implant were classified as a Class 2 medical implant recall. Specifically, the company’s notification to clinicians of new revision rate information regarding the use of the devices was cited as a reason for the DePuy ASR hip recall.
The manufacturer initially indicated that their decision to remove the device from the market was not issued due to any safety problems with DePuy ASR hip cups, rather because of low sales numbers. However, on March 6, DePuy sent a letter to doctors indicating that the ASR hip implant has been linked to a high failure rate. Many patients who received DePuy ASR hip replacements have experienced hip failures soon after the device was implanted, leading to additional hip surgeries.
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Learn MoreThe DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.
The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. 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.
Between 2007 and 2009, reports of problems with the DePuy ASR hip began to spike, with nearly 100 recipients reporting problems in 2007, more than 200 reporting problems in 2008, and more than 300 reporting problems in 2009. 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.
In recent months, a number of DePuy hip lawsuits over faulty ASR Cup implants have been filed. It is expected that the number of cases will continue to grow as Depuy ASR recall lawyers continue to investigate and review potential cases for individuals who have experienced problems and complications after hip replacement surgery involving the device.
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CatherineSeptember 26, 2010 at 1:23 am
I had an ASR done in 2008 and have had popping ever since. It never really has been pain free but I have tolerated it, thinking this was normal and would subside with time. Now I feel pain in my thigh and groan. I don't do much but sitt around in hopes of saving the hip. Had the other one done many years ago and it is nothing like this one. Not sure what to expect. Very concerned and disapointine[Show More]I had an ASR done in 2008 and have had popping ever since. It never really has been pain free but I have tolerated it, thinking this was normal and would subside with time. Now I feel pain in my thigh and groan. I don't do much but sitt around in hopes of saving the hip. Had the other one done many years ago and it is nothing like this one. Not sure what to expect. Very concerned and disapointined. Doctors tell me it is expected healing. Any help appriciated??
jackieSeptember 2, 2010 at 2:45 pm
my friend just had a hip replacement on august 17 2010 aqnd told me theday after that it didnt feel like the first one on the opposite side has been in alot of pain since then she received a letter fropm depuy saying her hip had been recalled what is wrong with these companies who keep putting peoples life ion danger all she wanted was to be free from pain now she is in worse pain then before
BarbaraAugust 27, 2010 at 6:27 pm
I had an ASR done in October 2008 and knew within weeks that there was something wrong. In March 2010 I had a THR and a ceramic plate put onto my pelvis after the ALVAL had destroyed a large part of my pelvis and the surrounding tissue. I am in constant pain, having weekly physio, using crutches on "bad" days and I trying to use walking sticks on "good" days. I feel so let down by DePuy and pray s[Show More]I had an ASR done in October 2008 and knew within weeks that there was something wrong. In March 2010 I had a THR and a ceramic plate put onto my pelvis after the ALVAL had destroyed a large part of my pelvis and the surrounding tissue. I am in constant pain, having weekly physio, using crutches on "bad" days and I trying to use walking sticks on "good" days. I feel so let down by DePuy and pray someone can find a cure to take this pain away and give me back my mobility.
sandraAugust 27, 2010 at 3:59 am
I have severe pain and have been on crutches 100% since Nov. 08, almost two years. Tonight I find out about the DePuy recall. I am in so much pain and almost total loss of movement day and night that I have discussed euthanasia soon!