The manufacturer became aware of a study from foot & ankle institute, clinique du parc léopold, bruxelles, belgium.The title of this study is ¿arthrodesis after failed total ankle replacement¿ and is associated with the star.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2003 and 2012.It was not possible to ascertain specific device catalogs from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 6 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses aseptic loosening and dislocation of mobile polyethylene insert (mpi).
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