Johnson & Johnson's medical device division DePuy Synthes has issued an urgent field safety notice for its Attune S+ knee replacement system after post-market surveillance revealed higher-than-expected rates of premature tibial component wear. Approximately 45,000 implants worldwide are affected.
Surgeons who implanted the devices between 2023 and 2025 are being notified to schedule follow-up imaging for their patients. The wear issue can lead to implant loosening, pain, and in some cases, the need for early revision surgery.
J&J reported that approximately 3% of patients with the affected implant are showing signs of accelerated wear within the first two years, compared to the expected rate of less than 0.5%. The issue appears related to a manufacturing process change in the polyethylene bearing surface.
Patients with the Attune S+ implant should contact their orthopedic surgeon for an evaluation, even if they are not currently experiencing symptoms. J&J is covering the cost of all follow-up imaging and any necessary revision procedures.
The recall is expected to result in significant financial liability for J&J, with legal experts predicting a wave of product liability lawsuits. The company's stock dropped 4% following the announcement.
