GMK PRIMARY TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON (B)(6) 2026 GMK-SPHERE 02.07.0035RP PATELLA RESURFACING S.3 (NEW GENERATION) ((B)(6) ) LOT 2010872: 240 ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 29-OCT-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 239 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIX CEMENTED S.5R ((B)(6) ) LOT 2219047: 50 ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 02-NOV-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0025R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 5+R ((B)(6) ) LOT 2236474: 14 ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 28-NOV-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0511FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 11 MM ((B)(6) ) LOT 2201080: 119 ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2026. EXPIRATION DATE: 26-JAN-2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 91 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.

Description of Event or Problem

AT ABOUT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.