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MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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The FDA is advising patients, caregivers, and health care providers about the higher than expected rate of device component fracture associated with the Scandinavian Total Ankle Replacement (STAR Ankle) device. This means a part of the STAR Ankle device is more likely to break than what was expected based on previous information.
This safety communication includes:
- Recommendations for patients, caregivers, and health care providers.
- Summary of the long-term post-approval study results and Medical Device Reports for STAR Ankle Replacements.
- Instructions for reporting to the FDA any problems with this device.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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