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Category : ASR Acetabular Cups
FDA Issues Another Warning to DePuy
In a warning letter published last week, the Food and Drug Administration announced that fourteen types of devices sold by DePuy Orthopaedics Inc. lacked necessary approval. The letter, sent by Steven D. Silverman, director of the office of compliance, was the result of a near month-long inspection of the Warsaw, Indiana-based company. The inspection also found that DePuy’s quality system did not comply with FDA requirements.
DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, has been the subject of significant FDA attention in the past. In 2010, the FDA released another warning letter regarding the manufacturer’s defective hip replacements, the ASR Hip Resurfacing System and the ASR XL Acetabular Cups System. These “metal on metal” hip replacements released dangerous metal shavings in patients, often leading to debilitating pain and other health complications. DePuy recalled the hip implants in 2010, and since then, Seeger Weiss LLP has been working with victims to restore their health and recover compensation for their suffering. If you have been affected by the DePuy ASR hip replacement recall, contact Seeger Weiss today. One of our experienced attorneys will review your case for free.
Johnson & Johnson and DePuy Orthopaedics Recall Defective Hip Replacements
On August 26, 2010, DePuy Orthopaedics, Inc. a subsidiary of Johnson and Johnson recalled both its ASR acetabular cups used in hip replacement arthroplasty and total hip replacements. The Johnson and Johnson recall comes more than two years after the Food and Drug Administration began receiving complaints and follows a determination that the failure rate for both ASR acetabular cups was more than 12%.
The ASR acetabular cups are a metal-on-metal device, a design that according to the New York Times, is coming under increasing scrutiny due to the potential for generating large amounts of metal debris during normal wear and tear. Such debris can negatively impact soft tissue and evolve into a health issue for some patients.
DePuy’s ASR cup, was approved for use in 2005 by the FDA but “was cleared through a regulatory pathway that did not require it to undergo clinical trials,” reports the New York Times.
Are you a victim?
Don’t wait. If you think you have had your hip replaced using DePuy’s ASR acetabular cups, contact Seeger Weiss today. Our experienced defective hip replacement attorneys can immediately assist you and discuss your legal options.
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