WASHINGTON, DC – The U.S. Food and Drug Administration issued an urgent safety communication Wednesday regarding Zimmer Biomet’s CPT Hip System, citing an increased risk of thigh bone fractures in patients with the implant.
The FDA’s warning comes after Zimmer Biomet initiated a voluntary recall on July 2 to update the device’s instructions. The company plans to phase out sales by December 2024.
Recent unpublished research from the United Kingdom found that patients with the CPT Hip System face a 1.4% risk of fracture around the thigh bone, significantly higher than the rates of 0.6% to 1% in similar devices.
The FDA recommends that healthcare providers consider alternative prostheses where possible. For patients already implanted with the device, the agency advises against removal if the implant functions well but urges vigilance for unexpected pain or difficulty walking.
Zimmer Biomet said in a statement that they are “working closely with the FDA to address these concerns and ensure patient safety remains our top priority.”
The CPT Hip System, a polished-taper slip-style stem made from cobalt-chromium alloy, is widely used in hip replacement surgeries.
This recall highlights ongoing challenges in medical device safety and the importance of post-market surveillance.
If you or a loved one has received a Zimmer Biomet CPT Hip System implant, you may be facing severe health risks and potential future medical expenses. Oliver Law Office stands ready to help you navigate this complex situation. Don’t wait for complications to arise. Contact Oliver Law Office today at 614-220-9100 or through our website to schedule a free, confidential case evaluation.
