GMK TOTAL KNEE SYSTEM

Description of Event or Problem

AT ABOUT 1 YEAR AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND SIGNS OF METAL ALLERGY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA S5+R CEMENTED FEMORAL COMPONENT TO A GMK-HINGE FEMORAL COMPONENT SIZE5 R - TINBN COATED, REVISED THE FLEX 5R - 10MM INSERT TO A SIZE5 - 14 MM GMK-HINGE INSERT, AND REVISED THE CEMENTED RIGHT S5 TIBIAL TRAY TO A GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 5R. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 04 JUNE 2026 GMK-SPHERIKA 02.12.KA15R GMK SPHERIKA FEMORAL COMPONENT S5+R CEMENTED (K211004) LOT 2422163: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2024. EXPIRATION DATE: 17-OCT-2029. 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 02.07.1205R TIBIAL TRAY FIX CEMENTED S.5R (K090988) LOT 2420949: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2025. EXPIRATION DATE: 08-DEC-2029. 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:THE REPORTED CAUSE WAS METAL ALLERGY WITH NO ALLEGED DEVICE DEFICIENCY INVOLVED, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.