DePuy Hip Replacement Recall: Senate to Probe Safety of Medical Devices

Nearly a year after voluntarily recalling its defective ACR hip replacement system, DePuy Inc. – a subsidiary of Johnson & Johnson – will once again be front and center.

The U.S. Senate’s Special Committee on Aging announced that the Warsaw, Ind.-based company’s massive hip replacement system recall will be featured during its examination of the FDA and its role in “protecting patient safety as part of the medical device approval process.”

DePuy is already embroiled in a $70 million deferred prosecution agreement Johnson & Johnson signed in early April.

The Senate committee will hear from patients affected by the recall, as well as some leading patient safety advocates.

“Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved,” the committee wrote. “The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”

DePuy Orthopaedics announced in August of 2010 that it was voluntarily recalling its ASR hip replacement system. The recall came after multiple reports that a higher-than-normal number of patients required additional surgeries to correct or remove defective implants. The company said it was pulling the ASR XL Acetabular ASR Hip Resurfacing systems from the market “due to the number of patients who required a second hip replacement procedure, called a revision surgery.”

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