Ankle Replacement Device Faces Higher Failure Risk: FDA Alert
March 8, 2024, 4:06 pm
FDA warns of increased risk of device failure with Hintermann Series H3 Total Ankle Replacement system. Patients and healthcare providers urged to be vigilant.
The FDA sounds the alarm on the Hintermann Series H3 Total Ankle Replacement (TAR) system, citing a higher-than-expected risk of device failure. Manufactured by DT MedTech LLC, this ankle replacement system is under scrutiny for a concerning rate of additional surgeries associated with the implanted device.
Interim post-approval study results reveal a spike in the need for removals or revisions of metal components, with a staggering 16.1% compared to the 9.9% rate in premarket clinical studies. When all types of revisions are considered, the rate of additional surgery climbs to at least 28.5%.
Patients contemplating the Hintermann Series H3 TAR system are advised to explore all treatment options for arthritic ankle joints with their healthcare provider. Understanding the benefits and risks of joint replacement devices is crucial in making informed decisions.
For those already with the Hintermann Series H3 TAR system, the FDA recommends avoiding surgery to remove it if the device is functioning well and there are no new or worsening symptoms. However, patients should promptly seek medical attention if they experience pain, swelling, difficulty bearing weight, unusual noises, or weakness around the implanted device.
Healthcare providers are urged to discuss treatment options thoroughly with patients, considering the heightened risk of device failure with the Hintermann Series H3 TAR system. Close monitoring for device problems, such as loosening and fractures, is essential to ensure patient safety.
The FDA is actively collaborating with the manufacturer to investigate the root causes of the increased failure rate and is committed to keeping the public informed of any significant developments. Patients and healthcare providers are encouraged to report any issues or complications with the Hintermann Series H3 TAR system to the FDA for further evaluation.
As the FDA continues its vigilance over the safety of medical devices, it underscores the importance of accurate reporting through the unique device identifier (UDI) system. This system allows for swift identification and correction of device-related problems, enhancing patient safety and regulatory oversight.
In a landscape where patient safety is paramount, staying informed and proactive is key. The FDA's alert serves as a reminder of the critical role patients and healthcare providers play in ensuring the efficacy and safety of medical devices.
The FDA sounds the alarm on the Hintermann Series H3 Total Ankle Replacement (TAR) system, citing a higher-than-expected risk of device failure. Manufactured by DT MedTech LLC, this ankle replacement system is under scrutiny for a concerning rate of additional surgeries associated with the implanted device.
Interim post-approval study results reveal a spike in the need for removals or revisions of metal components, with a staggering 16.1% compared to the 9.9% rate in premarket clinical studies. When all types of revisions are considered, the rate of additional surgery climbs to at least 28.5%.
Patients contemplating the Hintermann Series H3 TAR system are advised to explore all treatment options for arthritic ankle joints with their healthcare provider. Understanding the benefits and risks of joint replacement devices is crucial in making informed decisions.
For those already with the Hintermann Series H3 TAR system, the FDA recommends avoiding surgery to remove it if the device is functioning well and there are no new or worsening symptoms. However, patients should promptly seek medical attention if they experience pain, swelling, difficulty bearing weight, unusual noises, or weakness around the implanted device.
Healthcare providers are urged to discuss treatment options thoroughly with patients, considering the heightened risk of device failure with the Hintermann Series H3 TAR system. Close monitoring for device problems, such as loosening and fractures, is essential to ensure patient safety.
The FDA is actively collaborating with the manufacturer to investigate the root causes of the increased failure rate and is committed to keeping the public informed of any significant developments. Patients and healthcare providers are encouraged to report any issues or complications with the Hintermann Series H3 TAR system to the FDA for further evaluation.
As the FDA continues its vigilance over the safety of medical devices, it underscores the importance of accurate reporting through the unique device identifier (UDI) system. This system allows for swift identification and correction of device-related problems, enhancing patient safety and regulatory oversight.
In a landscape where patient safety is paramount, staying informed and proactive is key. The FDA's alert serves as a reminder of the critical role patients and healthcare providers play in ensuring the efficacy and safety of medical devices.