The US Food and Drug Administration (FDA) has raised concerns about the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper, citing an increased risk of thigh bone fractures after surgery.
The CPT Hip System Femoral Stem 12/14 Neck Taper is used in hip replacement surgeries and is a polished-taper slip style stem made from cobalt chromium alloy.
The regulator has issued a safety communication to alert patients, caregivers, and healthcare providers about these risks. This follows Zimmer Biomet’s voluntary recall of the product in July 2024 and its decision to phase out the device by December 2024.
Research has indicated a higher risk of postoperative periprosthetic femoral fractures in patients who have had the CPT Hip System implanted. These fractures, occurring in the thigh bone, may require surgical intervention.
The FDA said that it is working with Zimmer Biomet to address these issues and ensure that healthcare professionals and patients are informed.
Despite the recall, the FDA remains concerned about the device’s continued use, particularly in new patients. The agency advises patients with the CPT Hip System to consult their healthcare providers, especially if they experience pain or difficulty walking.
For those without symptoms, regular follow-up appointments should continue, and the FDA does not recommend the removal of a well-functioning device. The FDA also encourages patients and caregivers to report any problems related to the CPT Hip System.
Healthcare providers have been advised by the regulator to consider alternative prosthetic devices where possible. If alternatives are not available, providers should inform patients of the increased risk of thigh bone fractures.
Providers are also being urged by the FDA to monitor patients with the CPT Hip System and report any issues.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has recently released data showing that patients with the CPT Hip System have a 1.4% risk of thigh bone fracture, compared to 0.6% to 1% for similar devices.
The FDA said that it continues to monitor the situation and is collaborating with international regulatory bodies to evaluate the performance of the CPT Hip System, pledging to inform the public of any new developments.
