|
|
UPDATE: Hintermann Series H3 Total Ankle Replacement System and Long-Term Risk of Device Failure: FDA Safety Communication
The FDA has updated the “Hintermann Series H3 Total Ankle Replacement System and Long-Term Risk of Device Failure” Safety Communication to alert patients, caregivers, and health care providers of the elevated long-term risk of device failure, higher-than-expected risk of revision surgery, and risk of polyethylene fracture (plastic breakage) observed in the Hintermann Series H3 Total Ankle Replacement (TAR) System, manufactured by DT MedTech LLC.
Based on our current assessment of the totality of data, we are updating our recommendations to patients, caregivers, surgeons, and health care providers. We recommend considering using other available treatment options where possible. The FDA continues to review available data from mandated postmarket studies, scientific literature, and other real-world data sources, including registry data, adverse event reporting, and information from the manufacturer.
Questions?
If you have questions, please contact the Division of Industry and Consumer Education.
|
|
|
|
