GMK TOTAL KNEE SYSTEM

Description of Event or Problem

THE PATIENT HAD KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY INSERTING ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 10 JULY 2026: GMK-SPHERIKA 02.12.KA05R GMK SPHERIKA FEMORAL COMPONENT S5R CEMENTED (K211004) LOT 2533842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2026. EXPIRATION DATE: 26-FEB-2031. 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 02.12.E0511FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM (K202022) LOT 2521360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2025. EXPIRATION DATE: 14-SEP-2030. 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 GMK TIBIAL TRAY CEMENTED RIGHT S5 (K090988) LOT 2524831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2026. EXPIRATION DATE: 16-MAR-2031. 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: 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.