DePuy Orthopaedics ASR XL hip device implant is one of the most complicated hip recalls in recent history. The case includes alleged deception, unreleased reports of failure and not one, but two devices. So can you understand the recall? The key is understanding its history.
DePuy Orthopaedics, Inc., the orthopedic branch of Johnson & Johnson, manufactured two hip implant products that were recalled in 2010: the ASR XL Acetabular System, a hip socket and the ASR Hip Resurfacing System, designed for “partial” replacements. (Only the ASR XL Acetabular System was used in the United States.)
In March 2010, DePuy issued an “advisory,” on some of its devises, indicating they were exhibiting early failure. The devices, however, stayed on the market.
In July 2010, a New York Times exposé exposed various reports of early failures with the DePuy device, prompting the implants to be finally recalled. The U.S. Food and Drug Administration also reported they knew about the early failure rates of the DePuy ASR XL hip implants since 2008, two years before the recall. They have received nearly 400 complaints of early failure rates, requiring patients to undergo difficult and dangerous revision surgery.
DePuy acknowledged the hip implant was experiencing decreased sales after its August recall, and later admitted to the higher than average failure rate.