September 25, 2012 by Arezu Sarvestani
The orthopedic giant warned the Hong Kong department of health that new data on the implants, gathered since 2010, suggests a 1.29% failure rate based on the National Joint Registry of England and Wales and a 1.12% failure rate based on the Australian Orthopaedic Association's National Joint Replacement Registry.
On their own the rates exceed the 1% benchmark established by the U.K.'s National Institute for Health and Clinical Excellence. Prior to 2010 registry data showed a 1% revision rate for the devices, according to the company.
"Smith & Nephew’s highest priority is to deliver safe and effective medical technology to benefit patients," Smith & Nephew spokesman Joe Metzger told MassDevice.com today. "As such, we have notified customers and regulatory bodies of a change to the indications for use for the Birmingham Hip Modular Head used during total hip replacement and revision.