DePuy Orthopaedics, a Johnson & Johnson subsidiary, has issued a voluntary recall on two of its hip replacement devices. The recall is for the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System.
According to the NYTimes, the company decided to issue a recall because of the high failure rate of the parts, which resulted in many patients needing a second hip replacement.
Also, mid August 2010, the FDA sent DePuy Orthopaedics a warning letter for illegally marketing an unapproved product in the US, and for the selling of a hip implant device that was not approved for use.
The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Symptoms and Signs that your hip replacement device may be defective:
- chronic pain
- problems walking
- loosening or detachment of the device
- fracturing of the bone around the implant
- dislocation of the implant parts
Johnson & Johnson has reported that an estimated 93,000 people will be affected by this recall. If you or someone that you know has had to undergo hip replacement surgery a second time due to a defective DePuy hip implant, or are experiencing any of the signs or symptoms above, contact our the Law Offices of Richard J. Serpe, PC for a free case review. We are accepting cases in all states.