Additional Information
- DePuy Hip Failures
- Timeline of Events
Timeline of Events
2005-2009 Timeline Surrounding DePuy Hip Implant Recall
- 2005: J&J/DePuy introduces the ASR hip replacement system in the United States after a regulatory clearance allowed approval without having to undergo clinical trials.
- 2008: The FDA receives 400 complaints from or about patients who had ASR devices installed.
- 2008: The MHRA (British equivalent of the FDA) finds "evidence of genetic damage in patients with certain metal hip implants.
- 2009: DePuy sends letter to US doctors stressing importance of proper positioning of hip implants without addressing any other specific concerns.
2010 Timelines Leading to Recall
- March 10, 2010: The New York Times reports that DePuy warned doctors that its ASR system was failing in certain weak-boned patients within a few years after the replacement surgery.
- July 17, 2010: The FDA notifies the public that DePuy is recalling its ASR hip implant cups (FDA recalls nos. Z-2031 through Z-2059-2010).
- August 19, 2010: FDA criticizes DePuy in a letter.
- August 26, 2010: J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System – a decision based on the over 12% of DePuy hip failures for both systems.
