The MHRA in the UK has issued a medical device alert for some metal-on-metal hip replacement systems. The affected products are MITCH TRH, Acetabular Cups / MITCH TRH modular heads when implanted with uncemented Accolade femoral stems.
The Problem
Increased rates of revision of metal-on-metal total hip replacements when MITCH Acetabular Cups/ MITCH TRH modular heads are used in combination with uncemented femoral stems.
Requested Action Orthopaedic Surgeons, clinics and hospitals have been advised:
• Do not implant MITCH acetabular/MITCH TRH modular heads in combination with uncemented Accolade femoral stems.
• Follow up symptomatic and asymptomatic patients implanted with this combination.
• Report all adverse reports to the MHRA, DePuy International and Stryker Orthopedics.
The MITCH TRH system is a metal-on-metal hip replacement system consisting of components that can be used in different combinatons to carry out either hip resurfacing arthroplasty or total hip replacement.
The system is manufactured by Finsbury Orthopaedics and was distributed in the UK by Stryker Orthopaedics between May 2006 and October 2011.
Analysis of data from the England and Wales National Joint Registry (up to the 10th March 2012 has shown that the cumulative revision rate for MITCH TRH Systems used in hip resurfacing arthroplasty is in line with relevant guidance from the National Institute for Health and Clinical Excellence (NICE) guidance, but that the cumulative revision rate for MITCH TRH system total hip replacements is higher than indicated as acceptable by the NICE.
Speaking today about the latest safety alert issued by the MHRA Liam Moloney a Kildare Solicitor said “ any person who has received these medical devices when they have had hip replacement surgery should immediately contact their Orthopaedic Surgeon and arrange a review appointment so that updated MRI scans, blood tests and examinations can be carried out to establish if the devices are functioning properly or not. Any person who is having symptoms of pain and limitation of movement should also arrange for a check-up.’’
