Devices

Safety Alert on Zimmer Hip System

FDA has issued a safety alert about an increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System).

In July, the company began a recall to update the device’s instructions for use, and it announced its plan to phase out the sale of the device by December. “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 alert says. The agency says it is working with the device maker to address these concerns.

FDA notes that recent research found that of the most commonly implanted hip stems in the United Kingdom patients with the CPT Hip System have the highest risk of fracture around the thigh bone at about 1.4%, and similar devices have fracture rates ranging from 0.6% to 1%.

The agency says it will continue to monitor device performance, reports of thigh bone fractures, and work with Zimmer Biomet to identify additional mitigation strategies as needed.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome