GMK PRIMARY TOTAL KNEE SYSTEM
Received Jul 9, 2026 · Event occurred Jun 23, 2026
Report 3005180920-2026-00675 · MDR key 25763502
Device
Generic name
Patella Resurfacing S.1 (new Generation)
Manufacturer
Medacta International SaModel number
02.07.0033RPLot number
2102134
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Implant Pain
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 30 JUNE 2026: LOT 2102134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2021. EXPIRATION DATE: 24-MAR-2026. 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 FOR THE REPORTED PATELLAR TRACKING ISSUE AND RELATED PAIN. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE. IN ADDITION, THERE IS NO INDICATION OF TRAUMA OR OF ANY DEVICE-RELATED ISSUE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem
THE PATIENT HAD PAIN DUE TO THE PATELLA NOT TRACKING PROPERLY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 4 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA PATELLA TO A COMPETITOR PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.