GMK SPHERE TOTAL KNEE SYSTEM

Description of Event or Problem

AT ABOUT 1 MONTH AFTER THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 10MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 JUNE 2026 GMK-SPHERE 02.12.E0210FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 10MM (K202022) LOT 2526536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2025. EXPIRATION DATE: 30-OCT-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. 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