GMK PRIMARY TOTAL KNEE SYSTEM
Received Jul 14, 2026 · Event occurred Jul 1, 2026
Report 3005180920-2026-00707 · MDR key 25813735
Device
Generic name
Tibial Insert Ps Fix S.4 / 10 Mm
Manufacturer
Medacta International SaModel number
02.07.0410PSFLot number
2418349
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Joint Laxity
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 7 JULY 2026: LOT 2418349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-OCT-2024. EXPIRATION DATE: 18-SEP-2024. 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:THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem
THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF A FALL OR TRAUMA. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE PS INSERT FROM A 10MM TO A 12MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.