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    FDA Requires DePuy ASR Hip Replacement Recall:

    The FDA reports a Class 2 medical implant recall for DePuy Orthopedics. DePuy, a subsidiary of Johnson and Johnson, has recalled their ASR hip replacement devices due to a reported high failure rate. Many patients have experienced hip failure soon after implant surgery in cup sizes ranging from 44mm to 70mm. This particular hip prosthesis is a metal-on-metal hip replacement system that was developed in 2005. Orthopedic surgeons have reported problems with the production of metallic debris between the metal ball and metal socket. The metal debris damages soft tissues and causes inflammatory reactions in the joint that leads to bone loss. Surgeons have estimated that one to three percent of all metal-on-metal hip implant recipients may experience problems and possibly need revision surgery due to the presence of metallic debris.

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    DePuy Accused of Marketing Unapproved Hip Replacement Systems:

    Johnson and Johnson have bucked heads with the FDA again in violation of regulations. The FDA issued a warning on August 19th to DePuy about illegally marketing a hip and knee joint replacement system. DePuy has been accused of marketing TruMatch Personalized Solutions System and the Corail Hip System illegally. DePuy was given 15 days to respond to this warning by taking corrective action or provide a reason for why corrective action cannot be taken. The FDA also ordered DePuy to stop marketing both devices. The FDA considers both devices to be unapproved medical devices, until the issue is resolved.

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