Zimmer Biomet Holdings, Inc ZBH announced plans to phase out its CPT Hip System by December.
The decision comes on the heels of a warning from the U.S. Food and Drug Administration (FDA), citing research showing a higher risk of postoperative fractures compared to similar hip replacement systems.
Patients with the CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System) face a 1.4% risk of thigh bone fractures. That’s higher than the 0.6%-1% fracture rates observed in similar devices.
Zimmer Biomet issued a recall in July to update the instructions for use due to concerns over a heightened fracture risk.
The CPT Hip System, 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 provider, especially if the CPT Hip System is involved.
Those already implanted with the device should remain vigilant for symptoms like pain and difficulty walking. Fractures often require further surgical intervention, which has raised alarm among healthcare providers.
The FDA does not recommend the removal of functioning devices without symptoms. The agency also suggests that healthcare providers consider alternative prostheses when possible.
The CPT Hip System should only be implanted in new patients when its benefits outweigh the risks or when other options are unavailable.
Price Action: ZBH stock is down 0.78% at $105.41 at last check Wednesday.
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