Regulator advises against using metal hip implants
MHRA issues warning over hip replacement combination after high failure rate
Concern over the use of metal-on-metal hip implants continues with the decision by regulators this week to recommend surgeons stop performing operations using a particular combination of devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medical Device Alert for the management of patients using Mitch TRH cup/heads made by Finsbury Orthopaedics, now part of DePuy Orthopaedics, in combination with Accolade femoral stems made by Stryker Orthopaedics.
The majority of patients implanted with metal-on-metal hip replacements have well-functioning hips and are at a low risk of developing any serious problems
The MITCH TRH hip 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. There are around 270 people with this combination in England and Wales according to the NJR.
Surgeons are being advised to stop using this combination because information from the England and Wales National Joint Registry shows it has an unacceptably high revision rate of 10.7% after four years of implantation.
The decision comes just a matter of weeks after the regulator called for patients with metal-on-metal hip replacements using implants of 36mm or more to be monitored annually for the life of the implant. The move aimed to minimise the risk of patients having to undergo further surgery to correct complications.
Analysis has shown that the revision rate for this combination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely
Dr Susanne Ludgate, clinical director of the MHRA, said: “The majority of patients implanted with metal-on-metal hip replacements have well-functioning hips and are at a low risk of developing any serious problems. Patients with metal-on-metal hip replacements should already be regularly monitored by their clinician.
“Analysis has shown that the revision rate for this combination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely.”
- Companies:
- DePuy International Ltd
- Stryker UK Ltd
- Medicines and Healthcare products Regulatory Agency
