GMK TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JULY 2026 GMK-SPHERIKA 02.12.KA23R GMK SPHERIKA FEMORAL COMPONENT S3R CEMENTED TINBN (K211004) LOT. 2522305: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JANUARY 2026. EXPIRATION DATE: 28 DECEMBER 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH ONE SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.E0314FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 14MM (K202022) LOT. 2502992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2025. EXPIRATION DATE: 11 MARCH 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH ONE SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.07.2803R FIXED TIBIAL TRAY SIZE 3 R - TINBN COATING (K202684) LOT. 2512139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 NOVEMBER 2025. EXPIRATION DATE: 10 NOVEMBER 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH ONE SIMILAR REPORTED EVENTS 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. IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

REVISION SURGERY DUE TO SOFT TISSUE LAXITY CAUSING INSTABILITY AFTER ABOUT 3 MONTHS FROM PRIMARY. THE SURGEON REVISED THE GMK-SPHERIKA FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY TO A GMK-HINGE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY ALONG WITH AUGMENTATIONS.