GMK HINGE TOTAL KNEE SYSTEM

Description of Event or Problem

AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 14MM GMK-HINGE SIZE 1 INSERT TO A SAME SIZE INSERT, AND REVISED THE 14MM TINBN COATED POST EXTENSION TO A SAME SIZE EXTENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 8 JUNE 2026 GMK-HINGE 02.09.0114H GMK-HINGE TIBIAL INSERT - SIZE1 - 14 MM (K130299) LOT: 2244229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2023. EXPIRATION DATE: 24-JAN-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09. HE14 GMK-HINGE POST EXTENSION 14 MM -TINBN COATED (K210010) LOT: 2517674: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2025. EXPIRATION DATE: 16-SEP-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.