Zimmer CPT Hip System: Elevated Risk of Femoral Fracture

Date Issued: September 17, 2024

The U.S. Food and Drug Administration (FDA) has issued a notification for patients, caregivers, healthcare providers, and medical facilities regarding the heightened risk of thigh bone fractures following surgery (postoperative periprosthetic femoral fracture) associated with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System).

On July 2, 2024, Zimmer Biomet began a voluntary recall aimed at updating usage instructions for the CPT Hip System due to this increased fracture risk. The company is also planning to discontinue sales of this device by December 2024. The FDA has raised concerns regarding the continued use of the CPT Hip System in new patients, following studies indicating a greater risk of thigh bone fractures with this device compared to other similar hip replacement devices, which might necessitate surgical intervention in the event of a fracture. The FDA is collaborating with the manufacturer to resolve these issues.

Guidelines for Patients and Caregivers

• Consult with your healthcare provider about the advantages and disadvantages of all available hip replacement options.
• Stay informed about the heightened risk of thigh bone fractures post-surgery with the CPT Hip System.
  • Reach out to your healthcare provider if you have received a CPT Hip System implant and notice unusual pain or difficulty walking.
  • If you do not have any unexpected symptoms, maintain your existing follow-up schedule; the FDA advises against the removal of a well-functioning CPT Hip System.
• Report any issues related to the CPT Hip System to the FDA.

Guidelines for Healthcare Providers and Facilities

• Review and discuss the above recommendations with your patients.
• Where possible, consider utilizing alternative prosthetic options.
  • Only proceed with implantation of the CPT Hip System in new patients when the advantages outweigh the risks and suitable alternatives are unavailable.
  • If alternatives are not available, inform the patient about the increased risk of postoperative periprosthetic femoral fractures associated with the CPT Hip System.
• Remain vigilant of the heightened risk of postoperative periprosthetic femoral fractures in patients who have an existing CPT Hip System implant.
• Report any incidents your patients encounter with the CPT Hip System to the FDA.

Device Overview

The CPT Hip System Femoral Stem 12/14 Neck Taper, used for hip replacements, consists of a polished-taper slip (PTS) style stem crafted from cobalt chromium alloy.

Heightened Risk of Thigh Bone Fracture

Recent studies indicate that there is an increased risk of thigh bone fractures following surgery with the CPT Hip System relative to hip replacement devices of a similar design.

According to data from the Medicines and Healthcare products Regulatory Agency (MHRA) released on September 4, 2024, an unpublished analysis revealed that the CPT Hip System demonstrates the highest fracture risk among commonly implanted PTS Hip Stems in the United Kingdom, with an approximate risk of 1.4%. In contrast, similar devices exhibit fracture rates ranging from about 0.6% to 1%.

FDA Measures

The FDA will persist in collaborating with Zimmer Biomet to ensure that all stakeholders are informed about the increased risk of thigh bone fractures associated with the CPT Hip System.

The FDA will monitor the performance of this device, reports of thigh bone fractures, and work alongside Zimmer Biomet to explore additional mitigation strategies as necessary.

The agency will also maintain cooperation with international regulatory bodies to review data and evaluate device performance.

The FDA commits to keeping the public updated as new significant information emerges.

Unique Device Identifier (UDI)

The FDA has implemented a unique device identification system designed to accurately track medical devices from manufacturing to patient usage in the United States. Additional information about UDI can be found at Unique Device Identification System (UDI System).

Reporting Device Problems

If you suspect any issues with your device, the FDA recommends that you submit a report via the MedWatch Voluntary Reporting Form.

Healthcare personnel working in facilities that fall under the FDA’s user facility reporting requirements should adhere to their establishments’ reporting protocols.

Need Assistance?

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

Further Information