21 August 2009
The Medicines and Healthcare products Regulatory Agency (MHRA), the government agency responsible for ensuring that medicines and medical devices are acceptably safe, has issued a warning about the MRS Cemented Stems manufactured by Stryker Orthopaedics. The MRS Cemented Stems are part of Stryker’s Global Modular Replacement System (GMRS).
These modular devices are used to revise failed joint replacements, or in the treatment of patients with severe bone loss due to cancer or trauma. There are seven different diameters of stem available for use in the lower limb, but they are not all intended for the same uses. The manufacturer recalled various lots of the MRS Cemented Stems in March 2009 due to a lack of instructions about how to use the different diameters. This caused concern that the wrong diameter stem may have been used in some patients.
If the smaller 8, 9 or 10mm MRS Cemented Stems have been implanted and were to fracture, then further revision is likely to be difficult because the patients have already suffered important bone loss.
Leigh Day & Co has resolved a number of medical device claims, including claims concerning the Hylamer prosthetic hip made by DePuy and the 3M Capital Stem. If you would like to talk to one of our specialist product liability lawyers, please contact Jill Paterson
on 020 7650 1311.
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