Is DePuy Orthopaedics facing yet another possible recall due to a defective medical device? August of 2010, the DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting to a revision surgery.
Due to the design of the ASR, the metal material was a leading factor in the failure. Adverse Event Reports disclosed to the Food and Drug Administration (FDA) that the DePuy ASR hip system is associated with “loosening, pseudotumour and metallosis” / (sic) metalosis.” Metallosis occurs when the DePuy ASR metal ball rubs against the metal cup which releases metal shavings of cobalt and chromium into the tissue and circulatory system. This causes tissue necrosis and osteolysis, killing or severely damaging body cells and tissue.
Four months after the recall an article written in the New York Times discussing the issues with DePuy hip replacements stated, “failures in new implants are much more likely rather than failures with new drugs because unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the ASR, that process unfolded with devastating results. ‘You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic.'” That August DePuy issued a recall for more than 90,000 of the DePuy ASR metal hip implants. Read more about the recall in The New York Times.
Now, concerns have developed about all metal-on-metal hip implant procedures causing surgeons and doctors to rethink implants. DePuy Orthopaedics still offers one other type of metal-on-metal hip implant, the Pinnacle. The Pinnacle has a slightly different design, using a cup and a liner, whereas the ASR only uses the metal cup. Patients and surgeons are able to choose a metal-on-metal, metal-on-ceramic, or a metal-on-polyurethane line to be inserted inside the metal outer cup for the Pinnacle. However, studies have shown the metal-on-metal option for the Pinnacle has proven to cause very similar problems as the ASR model, mainly concerning the release of metal shavings of cobalt and chromium into the tissue and circulatory system.
In May 2011, nearly 60 DePuy hip lawsuits were incorporated in multidistrict litigation (MDL), all citing problems with the Pinnacle procedure. As of today, DePuy claims their Pinnacle device is safe, and any problems that have been accounted for are from surgeon error, though the Pinnacle is the subject of these recent lawsuits and were recently concentrated in the Northern District of Texas.
If you think you have a DePuy ASR or Pinnacle hip system, contact Borchardt Law Firm, LLP. We can immediately assist you and discuss your legal options.
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