Hip Implant Recall
Written by Faith Anderson on April 5, 2012
High Failure Rate of Hip Implants
The MITCH TRH components affected by this warning were manufactured by Finsbury Orthopaedics and distributed by Stryker in the U.K. From May 2006 to October 2011. Finsbury was acquired by DePuy Orthopaedics in 2009, which is a division of medical device maker Johnson & Johnson. This most recent hip implant warning came on the heels of an analysis of data from the England and Wales National Joint Registry (NJR), which found a cumulative revision rate of 8.8% for MITCH TRH hip resurfacing systems, a rate higher than what the U.K.’s National Institute for Health and Clinical Excellence (NICE) considers acceptable. In addition, when the DePuy MITCH hip is combined with the Accolade femoral stems, the failure rate increases to 10.7%. The notice issued by the U.K. is the latest in a string of warnings regarding metal-on-metal hip implants, which have been the target for an increasing number of calls for industry-wide recalls.
FDA Warnings and Recalls for Metal-on-Metal Hip Implants
In August 2010, a DePuy ASR metal-on-metal hip system recall was issued after it was found that approximately one out of every eight of the hip implants was failing within five years of surgery. More than 3,500 individuals throughout the United States are now pursuing a defective hip implant lawsuit after suffering from side effects of the medical device. Similar product liability lawsuits have also been filed over issues with other metal-on-metal hip systems, such as the DePuy Pinnacle, BioMet M2A-Magnum, and Wright Medical Conserve Plus. In May 2011, the FDA requested that manufacturers obtain more information about how much metal hip replacements shed, the level at which the metal particles become dangerous, and what the potential side effects of metallosis are. Last week, the FDA announced that an independent panel of experts will convene this summer to review the safety concerns associated with metal-on-metal hip implants, and to make recommendations about any regulatory actions that should be taken to protect consumers from dangerous hip implants.
Recommendations for Recipients of Hip Implants
MHRA has recommended that patients who received the DePuy MITCH and Stryker Accolade implant combination be tested annually for signs of high blood metal ions from the hip implant, which could indicate that they are suffering from a form of metal blood poisoning called metallosis. Those who have a blood metal ion level greater than seven parts per billion should get a second blood test three months later to see if the number increases, which could indicate the potential for soft tissue damage. In instances where high levels of metal ions are detected, MHRA advises that the patient undergo an ultrasound or magnetic resonance imaging to look for potential damage.