More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup

April 16, 2012 by MassDevice staff

More warnings on metal-on-metal implants, this time overseas; also, ITGI surges on cranial stent CE Mark; Spacelabs Healthcare wins 510(k) for Qube monitoring system; FDA gives Chromogenex clearance for i-Lipo fat laser; Custom Spine wins 510(k) for cannulated screw system.

hip x-ray

Regulators in the U.K. and New Zealand are warning again about higher-than-expected revision rates for certain metal-on-metal total hip replacement systems that use a combination of components made by Johnson & Johnson's (NYSE:JNJ) DePuy Orthopedics division and Stryker (NYSE:SYK).

The Medicines & Healthcare products Regulatory Agency, an executive agency of the U.K. Dept. of Health, issued a warning yesterday about elevated revision rates for Mitch TRH acetabular cups and Mitch TRH modular heads manufactured by DePuy's Finsbury Orthopaedics unit when used in combination with uncemented Accolade femoral stems manufactured by Stryker Orthopedics.

The revision rate for a less-invasive procedure using the Mitch TRH device, called hip resurfacing arthroplasty, fall in line with guidance, according to the regulators.

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"But that the cumulative revision rate for Mitch TRH System total hip replacements (revision rate of 8.8% at 4 years based on 445 patients recorded by the NJR) is higher than indicated as acceptable by the National Institute for Health and Clinical Excellence," according to the agency.