Smith & Nephew (NYSE:SNN) today said it’s voluntarily yanking some of the smaller components used with its flagship Birmingham hip replacement, after reviewing data showing that the smaller devices have a higher revision rate that larger sizes.
The British orthopedic device maker said a review of data in the U.K.’s National Joint Registry of England & Wales found revision rates in men implanted with the smaller devices, and all women, "exceed the current benchmark established by the U.K. National Institute for Health & Care Excellence.
"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 [indications for use] to contraindicate the BHR for women," the company said, noting that its review "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."
"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," added chief medical officer Dr. Andy Weymann.
Smith & Nephew ruled out proactive revisions in patients with the smaller components unless clinically indicated. The move is not expected to effect full-year guidance, the company said.