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Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

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UPDATE:

On September 18, 2024, Zimmer Biomet sent a follow-up letter to U.S. surgeons that included the FDA’s recommendations from this safety communication, a plain language communication that surgeons can share with patients, and plans for the CPT Hip System Femoral Stem to be exited in the U.S. 

Date Issued: September 17, 2024

The U.S. Food and Drug Administration (FDA) is alerting 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).

On July 2, 2024, Zimmer Biomet initiated a voluntary recall to update instructions for use for the CPT Hip System due to an increased risk of thigh bone fracture. The manufacturer 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, given recent research that found a higher risk of thigh bone fracture with the device compared to hip replacement devices of a similar design, and the likely need for surgical intervention if the fracture occurs. The FDA is working with the manufacturer to address these concerns.

Recommendations for Patients and Caregivers

  • Discuss the benefits and risks of all available hip replacement devices with your health care provider.
  • Be aware of the increased risk of thigh bone fracture after surgery with the CPT Hip System.
    • Consult with your health care provider if you have received a CPT Hip System implant, and you have unexpected symptoms of pain and difficulty when walking.
    • Continue with your existing follow-up schedule for your CPT Hip System if you do not have unexpected symptoms; the FDA does not recommend removal of a well-functioning CPT Hip System.
  • Report any problems with the CPT Hip System to the FDA.

Recommendations for Health Care Providers and Facilities

  • Review and discuss the Recommendations for Patients and Caregivers above with your patients.
  • Consider using an alternative prosthesis where possible.
    • Only implant the CPT Hip System in new patients when the benefits of implanting the device outweigh the risks, and when appropriate alternative devices are not available.
    • If no alternatives are possible, then inform the patient of the increased risk of postoperative periprosthetic femoral fracture with the CPT Hip System and why it may be an appropriate treatment option for them.
  • Be aware of the increased risk of postoperative periprosthetic femoral fracture in patients already implanted with the CPT Hip System.
  • Report any problems your patients experience with the CPT Hip System to the FDA.

Device Description

Used for a hip replacement, the CPT Hip System Femoral Stem 12/14 Neck Taper is a polished-taper slip (PTS) style stem made from cobalt chromium alloy.

Increased Risk of Thigh Bone Fracture

Recent research found a higher risk of thigh bone fracture after surgery with the CPT Hip System compared to hip replacement devices of a similar design.

Based on information the Medicines and Healthcare products Regulatory Agency (MHRA) released on September 4, 2024, a currently unpublished 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 approximately 1.4%, and similar PTS Hip Stems have fracture rates ranging from approximately 0.6% to 1%.

FDA Actions

The FDA 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.

The FDA will also continue to monitor device performance, reports of thigh bone fractures, and work with Zimmer Biomet to identify additional mitigation strategies as needed.

The FDA will continue to collaborate with international regulatory agencies to review data and further evaluate device performance.

The FDA will keep the public informed if significant new information becomes available.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI System).

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

Additional Resources

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