GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 16, 2026 · Event occurred Jul 3, 2026
Report 3005180920-2026-00738 · MDR key 25838719
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 4l - 14mm
Manufacturer
Medacta International SaModel number
02.12.E0414FLLot number
2403368
Product problems
- Device Appears to Trigger Rejection
Patient
NA · Male
- Medical device site infection
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 15 JULY 2026: LOT. 2403368: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2024. EXPIRATION DATE: 2029-MAR-05. 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.
Description of Event or Problem
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 MONTHS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX 4L - 14MM INSERT TO A SAME SIZE INSERT.