GMK REVISION TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 07 JULY 2026 GMK-REVISION 02.07.0214SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 14 MM (K103170) LOT. 189526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2018. EXPIRATION DATE: 2023-NOV-11. 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. SCP14 TINBN COATED SC PEG - 14MM (K210010) LOT. 2209288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2022. EXPIRATION DATE: 2027-JUN-23. 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. 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

REVISION SURGERY DUE TO INFECTION AFTER ABOUT 3 YEARS AND 7 MONTHS FROM FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE TINBN COATED SC.