GMK HINGE TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 20 JULY 2026 LOT 2316094: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2023. EXPIRATION DATE: 04-OCT-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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.

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 YEARS AND 1 MONTH FROM PRIMARY. THE SURGEON REVISED THE 20MM INSERT AND POST EXTENSION TO A 26MM INSERT AND POST EXTENSION AT HIS DISCRETION.