DePuy Hip Implant Recall

Johnson & Johnson announces the hip implant recall and withdrawal of its DePuy asr hip replacement system after reports indicate a high failure rate showing one in eight patients may need revision surgery within five years.

Background:

DePuy Orthopaedics is recalling its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. 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 replacements, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

The FDA indicated on July 17, 2010 that the actions of DePuy Orthopaedics, a subsidiary of Johnson and Johnson, in regards to its depuy 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.

On March 6, 2010, DePuy sent a letter to doctors indicating that the depuy 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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