The FDA issued a warning about the increased risk of thigh bone fractures post-surgery with the use of the Zimmer Biomet CPT Hip System.
Zimmer Biomet issued a voluntary recall of the system on July 2 to update instructions and plans to phase out the sale of the device by December 2024, according to a Sept. 17 news release.
The federal agency has raised concerns about the continuation of using the system for implants in new patients due to recent research that found the CPT Hip System has a higher risk of thigh fracture compared to similar hip replacement devices.
For patients that have a well-functioning CPT Hip System, the FDA does not recommend removal of the implant but to continue the existing follow-up schedule. If a patient has received the implant and is experiencing unexpected pain and difficulty when walking, the FDA recommends consulting with a healthcare provider.
The FDA is recommending that healthcare providers and facilities use an alternative prosthesis or implant when possible and to only use the CPT Hip System in new patients if the benefits outweigh the risks.
Zimmer Biomet and the FDA will continue working together to ensure patients and providers are aware of the increased risk of thigh bone fracture when using the system, the release said.