UK Hip Failure Rate Warning with DePuy MITCH and Stryker Accolade Hips

U.K. health officials have issued a high failure rate warning that states patients who received metal-on-metal hip replacement components of DePuy MITCH and Stryker Accolade are experiencing increased hip failure problems.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert on April 2, stating that there is an increased rate of revision surgery among patients who had a DePuy MITCH acetabular cup/modular head used in combination with uncemented Stryker Accolade femoral stems.

MHRA 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 Problem

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.

Analysis of data from the England and Wales National Joint Registry (NJR) has shown that the cumulative revision rate for MITCH TRH System used in hip resurfacing arthroplasty (revision rate of 3.1 % at 4 years) 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 (revision rate of 8.8% at 4 years) is higher than indicated as acceptable by NICE.

MITCH TRH total hip replacements consist of MITCH TRH acetabular cups used with MITCH TRH modular femoral heads and also an appropriate Stryker femoral stem with a V40 taper including Exeter V40 or uncemented Accolade or ABG II.

Action Recommended

• Do not implant MITCH TRH acetabular cups/MITCH TRH modular heads in combination with uncemented Accolade
femoral stems.

• Follow up both symptomatic and asymptomatic patients implanted with this combination.

• Report all adverse incidents to the MHRA, DePuy International and Stryker Orthopaedics.

MHRA indicated that patients who received the implant combination should be tested annually for signs of elevated cobalt and chromium blood levels from the hip replacement, which could indicate that they are suffering from metallosis.

Patients who have elevated cobalt and chromium blood levels, are recommended that they should get a second blood test three months later.

In cases where high levels of metal ions are detected, MHRA recommended that the patient undergo an ultrasound or magnetic resonance imaging to look for potential damage.

The warning is another nail in the coffin for metal-on-metal hip resurfacing and replacement systems, which have been the target for an industry-wide metal-on-metal hip recall.

In August 2010, a recall for the DePuy ASR metal-on-metal hip system was issued after it was discovered that many hip implants were failing within five years of surgery. More than 3,500 people throughout the United States have filed a DePuy ASR hip lawsuit after experiencing problems with the implant.

Many product liability lawsuits have been filed over problems with other metal-on-metal hip systems, including the DePuy Pinnacle, Wright Medical Conserve Plus and the BioMet M2A-Magnum.

In May 2011, the FDA asked device manufacturers to obtain more information about the danger level of the metal particles released by hip replacements, how much metal they actually release and the potential side effects of metallosis.

Last week, the FDA announced that a panel of experts will review the safety concerns with metal-on-metal hip replacement and resurfacing systems, and make recommendations about any regulatory actions that should be taken to protect consumers from the risks associated with cobalt and chromium that may be released into the body.