Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients, caregivers, health care providers, and health care facilities about the increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System).
Given recent research that found a higher risk of thigh bone fracture with the CPT Hip System compared to hip prostheses of a similar design, the FDA recommends health care providers and facilities consider using an alternative prosthesis where possible.
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This safety communication provides:
- A list of affected devices.
- Important recommendations for patients and caregivers.
- Important recommendations for health care providers and health care facilities.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with the CPT Hip System to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
