GMK REVISION TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 23 JUNE 2026 GMK-REVISION 02.07.2404R FEMUR REVISION PS CEMENTED S.4R (K102437) LOT. 2403984A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUNE-2024. EXPIRATION DATE: 2029-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0684R REVISION TIBIAL TRAY SIZE 4 RIGHT - FINISHING (K123721) LOT. 2312234: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2023. EXPIRATION DATE: 2028-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0414SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.4 / 14 MM (K103170) LOT. 2343105: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2023. EXPIRATION DATE: 2028-11-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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.

Description of Event or Problem

THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVE ALL REVISION IMPLANTS FROM THE (B)(6) 2025 SURGERY. THE SURGEON PLACE ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.