Thursday, October 13, 2011

The DePuy ASR Recall On CBS Atlanta News

The video of a news story by Stephany Fischer of CBS Atlanta News is shown here:

DePuy declined an interview with after their request but did make the following statement:

DePuy’s top priority is and always has been patient safety. In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System. This data showed a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System, which was not in line with previously reported data.

DePuy’s previous analyses of collective post-market data from a variety of sources — including national joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports — had shown lower revision rates.
We understand that this recall is concerning for patients, their family members and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need.

DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary. DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs. …”

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