Regulators in the U.K. have issued yet another metal-on-metal hip implant warning, this time for a specific brand of all-metal hip implant device. According to the Medicines and Healthcare products Regulatory Agency (MHRA), a total hip implant consisting of MITCH TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics, has an unacceptable failure rate and should no longer be used.
The MHRA also recommended close monitoring of the 271 patients in England and Wales who already received the device named in the warning during total hip replacement surgeries. The warning does not apply to patients who received the MITCH TRH implant during hip resurfacing procedures.
According to the MHRA announcement, the National Joint Registry for England and Wales shows the implant has a revision rate of 10.7% just four years after initial surgery.
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 and was distributed in the UK by Stryker Orthopaedics
between May 2006 and October 2011. DePuy International acquired Finsbury Orthopaedics in 2009 and they are now responsible for the safety and monitoring of the MITCH TRH hip system, the MHRA said.
In February, the MHRA 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.
Concerns about all makes of metal-on-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip implants, following findings that they were failing in about 12 percent of patients within five years. 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.
Last week, 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.