GMK HINGE TOTAL KNEE SYSTEM
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 3005180920-2026-00711 · MDR key 25778109
Device
Generic name
Gmk-hinge Femoral Component L - Size6
Manufacturer
Medacta International SaModel number
02.09.2606LLot number
172034
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Aseptic loosening
Narrative
Description of Event or Problem
REVISION SURGERY AFTER 8 YEARS AND 4 MONTHS DUE TO A LOOSE FEMORAL COMPONENT. THE SURGEON REVISED THE COMPONENT AND THE LINER. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 10 JULY 2026: LOT 172034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2017. EXPIRATION DATE: 23-MAY-2022. 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. FEMORAL COMPONENT LOOSENING IS A KNOWN POSSIBLE POST-OPERATIVE COMPLICATION OF TOTAL HIP ARTHROPLASTY. THERE IS NO INDICATION THAT A POTENTIAL DEVICE-RELATED ISSUE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFORMATION CURRENTLY AVAILABLE.