GMK HINGE TOTAL KNEE SYSTEM

Description of Event or Problem

REVISION SURGERY AFTER 1 MONTH FROM THE PRIMARY DUE TO INFECTION. THE SURGERY WAS SUCCESSFULLY COMPLETED.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026 GMK-HINGE 02.09.0417H GMK-HINGE TIBIAL INSERT - SIZE4 - 17 MM (K130299) LOT. 2412970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2024. EXPIRATION DATE: 27-JUNE-2029. 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. GMK-HINGE 02.09.HE17 GMK-HINGE POST EXTENSION 17 MM -TINBN COATED (K210010) LOT. 2521938: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2025. EXPIRATION DATE: 03-DEC-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.