GMK HINGE TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 12 JUNE 2026 GMK-HINGE 02.09.0217H GMK-HINGE TIBIAL INSERT - SIZE2 - 17 MM (K130299) LOT: 2247580: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAR-2023. EXPIRATION DATE: 12-FEB-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. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT AND REMOVED SCAR TISSUE, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT MOBILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO A MEDACTA GMK-HINGE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY. ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING STIFFNESS IN EXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR PATELLA TO A SIZE 2 MEDACTA PATELLA, AND THE GMK-HINGE SIZE 2 INSERT FROM 17 MM TO 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.