Birmingham Hip components withdrawn after new medical study
MEDICAL technology group Smith & Nephew has withdrawn components from its Birmingham Hip Resurfacing System after reviewing new data.
The group, whose UK orthopaedics operation is based at Warwick Technology Park, said it was announcing the voluntary removal from the market of 46mm diameter and smaller femoral heads and corresponding acetabular cup components for the BHR system and issuing new instructions for use in line with the performance data.
It said surgeons had been advised to maintain their routine follow-up protocol for patients, and patients would not be required to take any new action.
Andy Weymann, 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, the group said it had conducted an analysis of recent National Joint Registry of England and Wales (NJREW) data. This indicated that the BHR continued to deliver performance in line with the best total hip replacements in men 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 exceeded 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,” it said.
“Smith & Nephew is not advising proactive revisions for existing patients unless required for clinical reasons.”
The removed products accounted for around 1% of Smith & Nephew’s global hip implant revenue in 2014, and 0.1% of group revenues.
It said the action it had taken would have no impact on guidance for the full year.
