Smith & Nephew issues a voluntary removal from the market of 46mm diameter and smaller femoral heads and corresponding acetabular cup components for the BIRMINGHAM HIP◊ Resurfacing (BHR) System

Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, announces the voluntary removal from the market of 46mm diameter and smaller femoral heads and corresponding acetabular cup components for the BIRMINGHAM HIP Resurfacing (BHR) System, and new Instructions for Use (IFU), reflecting recent performance data. Surgeons should maintain their routine follow-up protocol for patients, and patients are not required to take any new action.

Andy Weymann MD, Smith & Nephew’s Chief Medical Officer, said: “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 that the BHR is only used in those patient groups where it has demonstrated strong performance. These represent the vast majority of current patients.”

As part of its normal post-market surveillance, Smith & Nephew has conducted an analysis of recent National Joint Registry of England and Wales (NJREW) data. This indicated that the BHR continues to deliver performance in line with the best total hip replacements in male patients under 65 requiring femoral head components 50mm in diameter and larger. However, 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 UK National Institute for Health and Care Excellence (NICE). Based on this information, Smith & Nephew considers that these patient groups may be at a greater risk of revision surgery than previously believed, and is therefore removing small sizes and updating the IFU to contraindicate the BHR for women.

Smith & Nephew is not advising proactive revisions for existing patients unless required for clinical reasons. As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon. BHR patients can also visit the website www.smith-nephew.com/BHR.

The removed products accounted for around 1% of Smith & Nephew’s global hip implant revenue in 2014, and 0.1% of Group revenues. This action will have no impact on guidance for the Full Year.