WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has issued a safety alert about the increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip System, which was recalled earlier.
The agency has alerted patients, caregivers, health care providers, and health care facilities, recommending them to consider using an alternative prosthesis where possible. If its not possible, they are asked to inform the patient of the increased risk.
The CPT Hip System Femoral Stem 12/14 Neck Taper, a polished-taper slip or PTS style stem made from cobalt chromium alloy, is used for a hip replacement.
Meanwhile, recent research found a higher risk of thigh bone fracture after surgery, called postoperative periprosthetic femoral fracture, with the CPT Hip System Femoral Stem 12/14 Neck Taper, compared to hip prostheses of a similar design.
In early July, Zimmer Biomet initiated a recall to update instructions for use for the CPT Hip System due to an increased risk of thigh bone fracture, and also announced its plan to phase out the sale of the device by December 2024.
However, the FDA has concerns about the CPT Hip System continuing to be implanted in new patients due to the higher risk of thigh bone fracture, and the likely need for surgical intervention if the fracture occurs.
The FDA said it is working with the manufacturer to address these concerns.
The alert was issued after the Medicines and Healthcare products Regulatory Agency or MHRA's analysis of the most commonly implanted PTS Hip Stems in the United Kingdom indicated that patients with the CPT Hip System have the highest risk of fracture around the thigh bone at around 1.4%. The similar PTS Hip Stems have fracture rates ranging from approximately 0.6% to 1%.
The FDA said it will continue working with Zimmer Biomet to help ensure that patients, caregivers, health care providers, and health care facilities are aware of the increased risk of thigh bone fracture with the CPT Hip System.
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