Medical Device Alert: Finsbury Mitch TRH Cup/Heads Combined With Stryker Accolade Femoral Stems

In short

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice to surgeons to stop using a particular combination of metal-on-metal total hip replacements because it has a high revision rate compared with other implants. The MHRA has also advised surgeons to closely monitor patients with this combination of implants.

Background 

The advice is included in a new MHRA Medical Device Alert, which can be found here. The alert has been issued to clinicians today for the management of patients the Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics.

Surgeons are being advised to stop using this combination of hip replacements because information from the England and Wales National Joint Registry (NJR) shows that it has an unacceptably high revision rate of 10.7 percent after four years of implantation. The MHRA is advising surgeons to follow up with patients with this combination of devices as previously advised here in February.

The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. Patients with the MITCH TRH resurfacing implants are not affected by this latest notification. There are around 270 people with this combination in England and Wales according to the NJR.

MHRA comments

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.

“We have previously taken prompt action in February to investigate safety concerns and provided advice on patient management to relevant healthcare professionals.”

Source: MHRA