GMK SPHERE TOTAL KNEE SYSTEM

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 MONTHS FROM PRIMARY.THE SURGEON PERFORMED A WASHOUT AND REVISED THE 12MM FLEX 5L INSERT TO A 13MM FLEX 5L INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JULY 2026 LOT. 2521361: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2025. EXPIRATION DATE: 2030-SEP-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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.