GMK HINGE TOTAL KNEE SYSTEM

Description of Event or Problem

REVISION SURGERY DUE TO A FRACTURED FEMUR AFTER ABOUT 2 MONTHS FROM PRIMARY AND THE CAUSE IS UNKNOWN. THE WAS NO INDICATION OF TRAUMA, BUT THE SURGEON DID NOTE POOR BONE QUALITY. THE SURGEON REVISED GMK-HINGE SIZE 5 FEMORAL COMPONENT TO A SAME SIZE FEMORAL COMPONENT AND REVISED THE GMK-HINGE 12MM INSERT TO A GMK-HINGE 14MM INSERT DUE TO LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 08 MAY 2026 GMK-HINGE 02.09.2605R GMK-HINGE FEMORAL COMPONENT R - SIZE5 (K130299) LOT. 2315255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2023. EXPIRATION DATE: 2028-SEP-16. 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 02.09.0612H GMK-HINGE TIBIAL INSERT - SIZE6 - 12 MM (K130299) LOT. 2215600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2022. EXPIRATION DATE: 2027-JUL-24. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.