GMK TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026: GMK-SPHERIKA 02.12.KA12R GMK SPHERIKA FEMORAL COMPONENT S2+R CEMENTED (K211004) LOT. 2337251: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024. EXPIRATION DATE: 2029-JAN-20. 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-SPHERIKA 02.07.1202R GMK TIBIAL TRAY CEMENTED RIGHT S2 (K090988) LOT. 2348216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2024. EXPIRATION DATE: 2029-FEB-12. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

REVISION SURGERY DUE TO LOOSE IMPLANTS WITH MINIMAL BONE INGROWTH AFTER ABOUT 2 YEARS FROM PRIMARY. THE SURGEON REVISED ALL GMK-SPHERIKA IMPLANTS EXCEPT THE PATELLA (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) TO GMK-HINGE DUE TO THE POSSIBLE COMPROMISE OF COLLATERAL LIGAMENTS.