Metal Hip Replacement Recalled in New Zealand Due to High Failure Rate

A Stryker and DePuy metal-on-metal hip replacement system, known as the MITCH THR, has been recalled in New Zealand due to a risk of loosening parts and a high failure rate. 

The MITCH THR metal hip replacement recall was announced by MedSafe, New Zealand’s health regulatory agency, on April 13.

The metal-on-metal hip replacement system has been used at least 41 times between 2006 and 2010 in New Zealand, and the government has instructed surgeons to contact all of the patients affected by the recall.

The system was distributed by Stryker in New Zealand, but was originally manufactured by Finsbury Orthopaedics Ltd., which was acquired by DePuy Orthopaedics in 2009. DePuy is a subsidiary of Johnson & Johnson.

While the MITCH THR was sold in New Zealand, Australia and the United Kingdom (U.K.), it is unclear whether the implant was ever sold or used in the United States.

The metal hip replacement was recalled after a medical device alert issued by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on April 2, indicating that there is an increased rate of revision surgery among individuals who had a DePuy MITCH acetabular cup/modular head used in combination with uncemented Stryker Accolade femoral stems.

The MHRA advised orthopedic surgeons not to use the components together and to follow up on all patients implanted with the combination of DePuy and Stryker components as part of a metal-on-metal total hip replacement.

The U.K. warning followed an analysis of data from the England and Wales National Joint Registry (NJR), which discovered a cumulative revision rate of 8.8% for MITCH TRH hip resurfacing systems.  That is higher than what the U.K.’s National Institute for Health and Clinical Excellence (NICE) considers acceptable, and when the DePuy MITCH hip is combined with the Accolade femoral stems, the failure rate jumps to 10.7%.

MHRA also indicated that patients who received the implant combination should be tested annually for signs of high blood metal ions from the hip replacement, which could indicate that they are suffering from metallosis, a form of metal blood poisoning.

Problems with metal-on-metal hip replacements have become an increasing concern within the medical community both in the United States and worldwide. All metal implants have been found to shed microscopic particles of metal into the body, which may increase the risk of early failure and other complications.

A Depuy ASR metal-on-metal hip recall was issued in August 2010, impacting 93,000 implants sold worldwide, including an estimated 40,000 sold within the United States. The recall was issued after DePuy acknowledged that a higher-than-expected rate were failing within a few years of surgery.

Johnson and Johnson and their subsidiary now face more than 3,500 DePuy ASR hip lawsuits filed by individuals throughout the United States who have experienced problems after receiving the implant.

A growing number of cases have also been filed in the United States involving other metal-on-metal hip replacements, including DePuy Pinnacle hip lawsuits, Wright Conserve hip lawsuits and Biomet Magnum hip lawsuits.

In May 2011, the FDA asked hip replacement manufacturers to obtain more information about metal-on-metal hip replacements, including the risk of metal poisoning and how much metal is actually shed by the devices. An independent panel of FDA advisors is scheduled to meet this summer to review all available data and make any recommendations about regulatory actions that should be taken in the United States to protect consumers from risks associated with metal-on-metal hip replacements.