HINTERMANN SERIES H2

Description of Event or Problem

VILEX BECAME AWARE OF AN EVENT INVOLVING THE H2 TOTAL ANKLE IMPLANT COMPONENTS ON (B)(6) 2026. THE PURPOSE OF THE EVENT SURGERY WAS TO REVISE AN EXISTING TOTAL ANKLE REPLACEMENT SYSTEM FROM A DIFFERENT MANUFACTURER. REP STATES THE TIBIAL SLIDE LOCKING MECHANISM, PACKAGED WITH THE TIBIAL COMPONENT, WAS INSERTED IN THE CORRECT ORIENTATION AND FAILED TO LOCK THE INSERTED POLY COMPONENT IMPLANT. ONCE IT WAS DETERMINED THAT THE LOCK WOULD NOT ENGAGE WITH THE POLY COMPONENT, THE TIBIAL AND POLY COMPONENTS WERE REMOVED, AND A NEW TIBIAL COMPONENT ASSEMBLY AND POLY ASSEMBLY WERE INSERTED. TOTAL DELAY IN SURGERY APPROXIMATELY 30 MINUTES.