Smith & Nephew Issues Urgent Medical Device Market Removal

Smith & Nephew is voluntarily removing from the market all lots of 46mm diameter and smaller femoral heads and corresponding acetabular cup components of the Birmingham Hip Resurfacing (BHR) System due to observed revision rates which are higher than established benchmarks.

This comes after data from the United Kingdom’s National Institute for Health and Care Excellence (NICE) found that smaller sizes of the Birmingham Hip Resurfacing System had revision rates that exceed its benchmarked expectations. Smith & Nephew is also advising against any use of the BHR system in women. However, the company is not advising patients with the now-contraindicated implant to undergo proactive revisions. Patients experiencing unusual symptoms are advised to contact their surgeon. Patients are not required to take any new action and surgeons can continue their current patient follow-up protocol.

Chief Medical Officer Andrew Weymann M.D. said in a news release, “Patient welfare is Smith & Nephew’s top priority. Based on our analysis of our most recent data, we are taking the necessary steps to ensure the Birmingham Hip Resurfacing is only used in those patient groups where it has demonstrated strong performance. These represent the vast majority of current patients.”