MISHA KNEE SYSTEM
Received Apr 2, 2025 · Event occurred Mar 4, 2025
Report 3008274656-2025-00003 · MDR key 21752756
Device
Generic name
Medial Knee Implanted Shock Absorber
Manufacturer
Moximed, Inc.Catalog number
2-1001
Lot number
23032901
Product problems
- Fracture
- Fracture
Patient
NA · Female
- Implant Pain
- Implant Pain
Narrative
Additional Manufacturer Narrative
AVAILABLE POST-OPERATIVE RADIOGRAPHS INDICATE THAT THE FEMORAL BASE WAS MALPOSITIONED AT TIME OF IMPLANTATION, INDICATIVE OF INTRAOPERATIVE USER ERROR. THE RETRIEVAL ANALYSIS IDENTIFIED IMPINGEMENT MARKS ON THE PISTON NECK AND FEMORAL SOCKET CONFIRMING MALPOSITIONING OF THE FEMORAL BASE RELATIVE TO THE ABSORBER. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE FRACTURED COMPONENT CONFORMED TO MANUFACTURING SPECIFICATIONS.
Description of Event or Problem
FRACTURE AT THE FEMORAL END OF THE ABSORBER WAS OBSERVED ON X-RAY AT ANNUAL DOCTOR'S VISIT. PATIENT COMMENTED ON TENDERNESS AROUND THE IMPLANT. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.
Description of Event or Problem
FRACTURE AT THE FEMORAL END OF THE ABSORBER WAS OBSERVED ON X-RAY AT ANNUAL DOCTOR'S VISIT. PATIENT COMMENTED ON TENDERNESS AROUND THE IMPLANT.
Additional Manufacturer Narrative
A DEVICE REMOVAL IS PLANNED. IF/WHEN EXPLANTED, RETURNED, AND THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.