Pharmaceutical products contaminated with fungal meningitis can result in serious illness and sometimes fatal infections among all members of the population,…
August 26, 2010
DePuy Orthopaedics, Inc. (a unit of Johnson & Johnson)
DePuy ASR XL Acetubular Hip System (on the market since 2004; sold worldwide)
DePuy ASR Hip Resurfacing System (on the market since 2003; sold exclusively outside the U.S.)
DePuy ASR XL Acetubular Hip System is a type of “metal-on-metal” hip implant. The device features a femoral head, a femoral stem in the thigh bone and a metal cup in the hip bone (acetabular). During implantation, the ball is attached to the taper of the stem. All of these components are made of metal (cobalt and chromium). These implants were once widely used in total hip replacement operations.
Reason for the Recall
The shallow nature of the cup in the DePuy ASR XL Acetubular Hip System is different than other metal-on-metal devices. The device may cause excessive heat and friction between the metal cup and the metal ball. Also, the size, design and location of the resurfacing cup are three important factors that relate to the release of metal ions in the body.
According to DePuy’s admission, the ASR hip implant’s five-year revision rate was 12-13 percent. In 2011, data from the British Orthopaedic Association and British Hip Society confirmed ASR failure rates ranged from 21 percent after four years to 49 percent after six years.
Timeline of Events Leading to Recall
DePuy begins marketing the ASR XL Acetubular Hip System as a high-performance implant that can benefit a younger, more active demographic.
Medical literature begins to emerge that discusses problems with the metal-on-metal (“MOM”) design.
DePuy quits marketing the implant in Australia.
Late 2009 / Early 2010
DePuy begins a “silent recall” that involves pulling inventory from the market and slowly decreasing sales.
March 8, 2010
DePuy issues an Urgent Field Safety Notice advising of a “higher than expected revision rate.” Consumers are notified at this time.
August 26, 2010
DePuy officially recalls the approximately 93,000 units of its ASR XL Acetabular System and ASR Hip Resurfacing System sold worldwide, citing an increase in the number of patients implanted with the device who needed revision surgery.
For More Information
- Metal-on-Metal Hip Implants, U.S. Food and Drug Administration
- Johnson & Johnson Recalls Hip Implants, The New York Times
- J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say, Bloomberg News
- F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants, The New York Times
- J.&J. Unit Phasing Out All-Metal Hip Devices, The New York Times
- DePuy ASR Hip Replacement Recall Guide, DePuy Synthes