Alert on Zimmer Biomet CPT Hip System

The U.S. Food and Drug Administration (FDA) issued an alert on Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System). This comes after findings indicated a higher risk of thigh bone fractures (postoperative periprosthetic femoral fractures) following hip replacement surgery with this device compared to other devices of similar design. As a result, Zimmer Biomet initiated a voluntary recall. They plan to phase out the CPT Hip System by December 2024.

Why Is the FDA Concerned?

Recent research highlighted that patients implanted with the CPT Hip System face a fracture risk. This risk is about 1.4%—significantly higher than the 0.6% to 1% fracture rates associated with other hip replacement devices of a similar design. The FDA’s concerns stem from the increased likelihood that patients may require surgical intervention if fractures occur post-surgery.

Despite the planned phase-out, the FDA is particularly worried about the continued use of the CPT Hip System in new patients. The FDA is working closely with Zimmer Biomet to address these concerns. They want to ensure patients and health care providers are well-informed.

Recommendations for Patients and Caregivers

Before surgery, patients should review all available hip replacement devices with their healthcare provider. If you have received a CPT Hip System implant, be aware of the increased risk of thigh bone fractures.

Watch for symptoms such as pain and difficulty walking. If no symptoms are present, maintain regular follow-ups with your provider. The FDA does not recommend the removal of a functioning CPT Hip System.

If you experience problems, report them to the FDA via the MedWatch Voluntary Reporting Form.

What Should Healthcare Providers Do?

Health care providers should consider alternatives to the CPT Hip System per the notice, especially if safer options are available. Only use the CPT Hip System in new patients if the benefits clearly outweigh the risks. If no alternatives are available, fully inform patients about the increased risk of postoperative thigh bone fractures.

Pay close attention to patients who already have the CPT Hip System, and report any adverse events to the FDA.

A Broader Concern: The Link to Exactech Recalls

The concerns surrounding Zimmer Biomet’s CPT Hip System recall echo another high-profile medical device issue: the recall of Exactech hip and knee replacement components. In 2021, Exactech recalled more than 140,000 hip, knee, and ankle replacement devices due to defects in packaging that led to premature wear and failure. Similar to the Zimmer Biomet situation, Exactech patients faced higher risks of device failure, leading to pain, difficulty walking, and in many cases, the need for revision surgery.

Both recalls highlight the growing importance of post-market surveillance of medical devices. The FDA’s heightened focus on transparency, safety, and long-term performance underscores the critical role patients and healthcare providers play in monitoring device performance and reporting issues.

Zimmer Biomet Details and the Recall Timeline

The Zimmer Biomet CPT Hip System is a polished-taper slip (PTS) style femoral stem made from cobalt chromium alloy, designed for use in hip replacements. Following the voluntary recall in July 2024, Zimmer Biomet has committed to phasing out the product by December 2024.

However, the FDA remains concerned about the ongoing use of the device in new patients, urging providers to prioritize alternatives when possible.

FDA Actions and Next Steps Regarding Zimmer Biomet

The FDA is actively monitoring the situation and collaborating with Zimmer Biomet to ensure that patients, caregivers, and healthcare providers are aware of the risks associated with the CPT Hip System. Additionally, the FDA continues to collaborate with international regulatory agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, which recently issued similar warnings based on unpublished analyses of PTS Hip Stems.

As more data becomes available, the FDA will update its guidance and continue to work with Zimmer Biomet to develop additional strategies for mitigating risks associated with the CPT Hip System.

What’s Next for Zimmer Biomet Patients?

If you have questions about the Zimmer Biomet CPT Hip System or if you’re considering a hip replacement, it’s crucial to discuss all options and potential risks with your healthcare provider. If you’ve already received this device, stay vigilant for symptoms and follow your regular follow-up schedule. For any issues or concerns, don’t hesitate to report them to the FDA and your healthcare team.

What Can KBA Do?

This unfolding situation with Zimmer Biomet mirrors the industry-wide challenges seen with other recalls like Exactech. Together, these cases remind us of the importance of ongoing device safety, transparent communication, and vigilant monitoring to protect patients’ long-term health and mobility.

Have you been injured by the Zimmer Biomet, Exactech, or other related products? Our law firm handles hip implant failures.  Contact us today for a free consultation to learn more about your case.