GMK PRIMARY TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 15 JULY 2026 LOT 2004701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2020. EXPIRATION DATE: 23-SEP-2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

Description of Event or Problem

REVISION SURGERY DUE TO TIBIAL SUBSIDENCE AFTER ABOUT 5 YEARS AND 4 MONTHS FROM PRIMARY. THE SURGEON REVISED TIBIAL TRAY AND INSERT. THE PATIENT HAD A FIRST REVISION SURGERY ON (B)(6) 2023 WHERE THE SURGEON REVISED THE FEMORAL COMPONENT AND TIBIAL INSERT (MDR 3005180920-2023-00515)-