GMK SPHERIKA CEMENTLESS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026 GMK-SPHERIKA 02.12.KA174R GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S4+R (K130299) LOT. 2432515: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2025. EXPIRATION DATE: 18-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.E0412FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 12MM (K202022) LOT. 2402554: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2024. EXPIRATION DATE: 25-FEB-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.3D04R GMK 3DMETAL TIBIAL TRAY SIZE 4R CEMENTLESS (K221850) LOT. 2435209: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2025. EXPIRATION DATE: 24-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE CAUSE OF THE EXTENSOR MECHANISM FAILURE IS UNKNOWN, AND THERE IS NO INDICATION OF TRAUMA. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT ANY POTENTIAL DEVICE-RELATED ISSUE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

REVISION SURGERY WAS PERFORMED APPROXIMATELY 1 YEAR AFTER THE PRIMARY PROCEDURE DUE TO PAIN AND INSTABILITY ASSOCIATED WITH A FAILED EXTENSOR MECHANISM. THE CAUSE OF THE FAILURE IS UNKNOWN AND THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA GMK-SPHERIKA IMPLANTS (FEMORAL COMPONENT, INSERT, TIBIAL TRAY) TO GMK-HINGE WITH EXTENSOR MECHANISM ALLOGRAFT.