The manufacturer became aware of an implant summary report from (b)(6).This national joint registry was produced on (b)(6) 2018 and is associated with ¿star ankle¿.Within that publication, post-operative complications/ adverse events were reported, which occurred between april 2010 and may 2018.It was not possible to ascertain specific device or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 22 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses soft tissue impingement.
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