MHRA issues new metal-on-metal hip replacement advisory
Posted 03 April 2012 | By
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advised surgeons to stop using a particular combination of metal-on-metal total hip replacements because of a high revision rate compared with other implants. The advice is included in a new MHRA Medical Device Alert targeting the Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics. Information from the England and Wales National Joint Registry (NJR) shows an unacceptably high revision rate of 10.7 percent after four years of implantation.
Metal hip joints have been the subject of scrutiny following reports of pain and swelling that have sometimes required removal. The U.S. Food and Drug Administration has asked device companies to conduct additional follow-up studies to monitor problems with the implants, and is planning a meeting on the subject in June to determine whether more rigorous testing and premarket review requirements are needed. In 2010, Johnson & Johnson recalled some 93,000 of the metal-on-metal implants.
Medical Device Alert: Metal-on-metal (MoM) total hip replacements (MDA/2012/016)