FDA issues alert for increased risk of fracture after surgery with CPT System

The U.S. Food and Drug Administration is alerting patients, caregivers, health care providers, and health care facilities about the increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper. On July 2, 2024, Zimmer Biomet initiated a voluntary recall to update instructions for use for the CPT Hip System due to an increased risk of thigh bone fracture. The manufacturer also announced its plan to phase out the sale of the device by December 2024. However, the FDA has concerns about the CPT Hip System continuing to be implanted in new patients, given recent research that found a higher risk of thigh bone fracture with the device compared to hip replacement devices of a similar design, and the likely need for surgical intervention if the fracture occurs. The FDA is working with the manufacturer to address these concerns. The FDA will continue working with Zimmer Biomet to help ensure that patients, caregivers, health care providers, and health care facilities are aware of the increased risk of thigh bone fracture with the CPT Hip System. The FDA will also continue to monitor device performance, reports of thigh bone fractures, and work with Zimmer Biomet to identify additional mitigation strategies as needed.