Smith & Nephew announced the voluntary removal of certain components of the BIRMINGHAM HIP Resurfacing System from the market.
Here are five things to know:
1. Smith & Nephew has removed the 46mm diameter and smaller femoral heads and corresponding acetabular cup components for the BHR System.
2. As part of its post-market surveillance, the company conducted an analysis of recent National Joint Registry of England and Wales data.
3. The data indicated that the revision rates associated with men requiring femoral head sizes 46mm or smaller and with all women patients exceed the current benchmark established by the U.K. National Institute for Health and Care Excellence.
4. Thus, "Smith & Nephew considers that these patient groups may be at a greater risk of revision surgery than previously believed," and is removing the components, according to the news release.
5. However, patients are not required to take any new action and surgeons can continue their current patient follow-up protocol.
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