GMK REVISION TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JUL 2026 GMK-REVISION 02.07.0220SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 20 MM (K103170) LOT. 2421684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEPT-2024. EXPIRATION DATE: 2029-SEPT-05. 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-REVISION 02.07.2802L FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING (K202684) LOT. 2428383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2025. EXPIRATION DATE: 2030-FEB-13. 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-REVISION 02.07.4402L TINBN COATED FEMUR REVISION PS SIZE 2 L (K210010) LOT. 2403231: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEPT-2024. EXPIRATION DATE: 2029-AUG-27. 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: DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

REVISION SURGERY DUE TO INSTABILITY AT ABOUT 8 MONTHS FROM THE PRIMARY. GMK REVISION SC EXPLANTED AND GMK HINGE IMPLANTED.