The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann Series H3 Total Ankle Replacement (TAR) system, citing a higher-than-expected rate of device failure. This notification, dated February 29, 2024, is relevant to patients, caregivers, and health care providers involved in the care or use of this system. It aims to improve awareness about the risks associated with this medical device and ensure informed decision-making regarding its use.
What has changed?
According to the FDA, new data from post-approval studies and real-world evidence have identified increased risks of device failure related to the Hintermann Series H3 Total Ankle Replacement system. Specifically, there is a notable rise in the rate of additional surgeries required to revise or remove device components. The statistics show a 14.9% revision rate for metal component removal or revision at 10 years, compared to 6.5% observed at 5 years. When all components—including polyethylene—are factored in, the rate rises to an estimated 31.8% at 10 years, up from 19.2% at 5 years.
Interim data also indicates that failure rates for the device exceed those observed during premarket clinical studies. The rate of revision surgeries for metal components increases to at least 16.1%, surpassing the 9.9% originally reported in clinical trials. When plastic and metal components are included, the rate climbs to at least 28.5%, underscoring concerns regarding the overall performance of the device.
What is the Hintermann Series H3 TAR system?
The Hintermann Series H3 TAR system is a mobile-bearing total ankle replacement device designed to replace a painful arthritic ankle joint caused by conditions such as osteoarthritis, post-traumatic osteoarthritis, or rheumatoid arthritis. It consists of three key components: a tibial metal plate, a polyethylene plastic inlay, and a talar metal ankle component. Approved in the United States in 2019, the device was cleared with requirements for two post-approval studies—a long-term 10-year follow-up study for premarket clinical trial participants and a new-enrollment 5-year follow-up study.
What are the FDA recommendations?
Guidance for Patients and Caregivers
- Patients considering the Hintermann Series H3 TAR system should discuss all available treatment options for painful arthritic ankle joints with their health care providers. Remember that all joint replacement procedures involve potential benefits and risks.
- If your implanted system is functioning well and you experience no new or worsening pain or symptoms, the FDA does not recommend surgery to remove it.
- Contact your health care provider promptly if you encounter issues such as new or worsening pain, swelling, grinding noises, inability to bear weight, or other symptoms. Depending on your condition, imaging tests like X-rays or CT scans may be ordered to evaluate your device.
- Report any complications experienced with your TAR system to the FDA through their MedWatch Voluntary Reporting Form. Your feedback contributes to improving device safety.
Guidance for Health Care Providers
- Discuss the benefits and risks of this device and alternative treatments with your patients as part of shared decision-making.
- Monitor patients with the Hintermann Series H3 TAR system for potential device complications such as loosening or fractures of the implant components.
- When fracture of the polyethylene component is suspected, consider imaging techniques such as X-rays and CT scans to verify device integrity. Keep in mind that abnormalities may be subtle on imaging.
- Ensure proper adherence to the device’s Instructions for Use.
- Report any problems or complications experienced by patients with this device to the FDA.
What factors contribute to device failure?
The FDA is actively collaborating with DT MedTech LLC, the manufacturer of the Hintermann Series H3 TAR system, to investigate potential causes of the device’s elevated failure rates. Additionally, they are working with international regulatory agencies to review data from mobile-bearing TAR registries and further evaluate device performance.
Device failure may involve various factors, including material degradation, design limitations, or complications inherent to mobile-bearing systems. Health care professionals remain key in identifying problems through patient monitoring and imaging diagnostics.
Conclusion
In light of evidence pointing to higher-than-expected failure risks associated with the Hintermann Series H3 TAR system, the FDA emphasizes the importance of informed decision-making for patients and caregivers. Health care providers play a vital role in monitoring device performance and reporting issues to the FDA to safeguard future device use.
Disclaimer
This summary is for informational purposes for clinical, quality, and regulatory professionals. It is not intended as legal advice or to replace medical consultation. Always seek appropriate professional guidance regarding medical devices.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/safety-communications/hintermann-series-h3-total-ankle-replacement-has-higher-expected-risk-device-failure-fda-safety