Fractures Form for Zimmer Biomet’s CPT Hip System

This week, FDA issued a safety communication connected to Zimmer Biomet’s CPT Hip System Femoral Stem after finding increased risk of thigh bone fracture — postoperative periprosthetic femoral fracture — after implantation.

The CPT Hip System Femoral Stem is used for hip replacements, includes a 12/14 neck taper and a polished-taper slip style stem made from cobalt chromium alloy. In July, Zimmer Biomet initiated a voluntary recall to update the instructions for use for the device due to an increased risk of such fractures and also announced its plan to phase out the sale of the system by December 2024.

However, in the safety communication, FDA said it 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 fracture information arose from the Medicines and Healthcare products Regulatory Agency, which reported that, according to a currently unpublished analysis of the most commonly implanted PTS Hip Stems in the United Kingdom, patients with the CPT Hip System have the highest risk of fracture around the thigh bone — approximately 1.4%. Similar PTS Hip Stems have fracture rates ranging from about 0.6% to 1%.

The agency is recommending that healthcare providers and facilities consider using an alternative prosthesis where possible and only implant the CPT Hip System in new patients when the benefits of implanting the device outweigh the risks. When no alternatives are possible, healthcare providers should inform patients of the increased risk of thigh bone fracture with the device.

Patients implanted with the CPT Hip System are being urged to consult with a healthcare provider if they experience unexpected symptoms of pain and difficulty when walking. Of note, FDA said it does not recommend the removal of a well-functioning system.

“The FDA will continue working with Zimmer Biomet to help ensure that patients, caregivers, healthcare providers, and healthcare facilities are aware of the increased risk of thigh bone fracture with the CPT Hip System,” according to the safety notice. “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.”