New Zealand Regulators Recall DePuy MITCH TRH Hip Implant ComponentApr 16, 2012 | Parker Waichman LLP
Regulators in New Zealand have recalled a DePuy metal-on-metal hip implant component for higher-than-expected failure rates. The implant, DePuy's MITCH TRH cup/heads, which are used with Accolade femoral stems made by Stryker Orthopaedics, had already sparked a health warning in the U.K when New Zealand's medical regulator, MedSafe, announced that patients with the DePuy MITCH TRH hip implant should see their doctors.
As we've reported previously, the MITCH TRH System is a metal-on-metal hip replacement system consisting of components that can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. The system was manufactured by Finsbury Orthopaedics, which was purchased by Stryker in 2010. Earlier this month, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) warned that the National Joint Registry for England and Wales shows the implant has a revision rate of 10.7% just four years after initial surgery.
According to a report from Radio New Zealand News, just over 40 people in New Zealand received the hip replacement, known as the MITCH THR, between 2006 - 2010. Three have since had them removed. MedSafe said Stryker, the distributor of the MITCH system in New Zealand, is contacting all surgeons who implanted the devices and asking them to contact their patients who received the MITCH THR implant.
The recall doesn't necessarily mean all MITCH THR implant recipients will need to have the devices removed, MedSafe said. Patients concerned that they may have a MITCH TRH implant should contact their doctor or surgeon for further information about the type of implant they have and what follow up, if any is required, MedSafe said.
Concerns about all varieties of metal-on-metal hip implants have increased significantly over the past year. Last May, the U.S. Food & Drug (FDA) directed 21 companies that market all-metal hip replacement to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. In March, authors of a study published in The Lancet said all-metal hip implants should no longer be used because of their high failure rates. The month prior, a report in the British Medical Journal raised fears that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic metals from failing metal-on-metal hip implants.
The British Hip Society has also called on surgeons to stop using all-metal hip implants in total hip replacement procedures. Regulators Britain in advised that patients fitted with large metal hip implants for total hip replacement – those with bearings of 36 mm or above – should undergo annual blood tests to check cobalt and chromium, as well as MRIs for any patient who does exhibit high metal ion levels.
Last month, the FDA announced that it would convene an advisory panel meeting in June to discuss the safety of all-metal hip replacement devices. The FDA’s Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip systems, as well as potential patient and practitioner recommendations for their use.