Zimmer Biomet Holdings, Inc. (ZBH) has announced that it will be phasing out its CPT Hip System by December. The decision comes after a warning from the U.S. Food and Drug Administration (FDA), citing research that indicates a higher risk of postoperative fractures with the CPT Hip System compared to similar hip replacement systems.
The FDA’s warning is based on research that found a 1.4% risk of thigh bone fractures in patients using the CPT Hip System Femoral Stem 12/14 Neck Taper. This fracture rate is significantly higher than the 0.6%-1% fracture rate observed in similar devices.
In response to these concerns, Zimmer Biomet issued a recall in July to update the instructions for use of the CPT Hip System. The CPT Hip System, which is made from cobalt chromium alloy, is a polished-taper slip (PTS) style stem commonly used in hip replacements.
Patients and caregivers are advised to discuss the risks and benefits of hip replacement devices with their healthcare providers, particularly if the CPT Hip System is involved. Those who have already had the CPT Hip System implanted should remain vigilant for symptoms such as pain and difficulty walking. Fractures often require further surgical intervention, which has raised concerns among healthcare providers.
The FDA does not recommend removing functioning devices without symptoms. However, the agency suggests that healthcare providers consider alternative prostheses whenever possible. The CPT Hip System should only be implanted in new patients when its benefits outweigh the risks or when other options are unavailable.
As of Wednesday, ZBH stock is down 0.78% at $105.41.
