Zimmer Biomet's Hip Replacement Device Increases Risk of Thigh Fracture, FDA Says
By Connor Hart
The Food and Drug Administration said hip replacement surgeries that use Zimmer Biomet's CPT Hip System result in a higher risk of thigh bone fracture.
The agency on Tuesday said recent research found a higher risk of thigh bone fracture with the device -- Zimmer Biomet's CPT Hip System Femoral Stem 12/14 Neck Taper -- compared with hip replacement devices of a similar design. If a fracture occurs, additional surgical intervention will likely be needed, it added.
The FDA's finding comes after Warsaw, Ind.-based Zimmer Biomet in July initiated a voluntary recall to update instructions for use for the CPT Hip System because of an increased risk of thigh bone fracture. The manufacturer also announced its plan to phase out the sale of the device by the end of the year.
The FDA recommended patients and caregivers discuss the benefits and risks of all available hip replacement devices, and that health-care providers and facilities consider using an alternative prosthesis where possible.
The agency said it will continue monitoring and reviewing data regarding the device's performance, and work with Zimmer Biomet to address its concerns.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
September 17, 2024 15:35 ET (19:35 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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