MISHA KNEE SYSTEM
Received Sep 9, 2025 · Event occurred Aug 11, 2025
Report 3008274656-2025-00004 · MDR key 23011837
Device
Generic name
Medial Knee Implanted Shock Absorber, Product Code: Qvv
Manufacturer
Moximed, Inc.Catalog number
2-1002
Lot number
23092503
Product problems
- Fracture
- Fracture
Patient
43 YR · Male
- Implant Pain
- Implant Pain
Narrative
Additional Manufacturer Narrative
THE FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS CONFIRMED UPON REMOVAL OF THE DEVICE. THE ROOT CAUSE IS A SUPPLIER ERROR. AN INCORRECT DRILL WAS USED RESULTING IN AN INACCURATE DRILL POINT ANGLE AND REDUCED MATERIAL THICKNESS. THIS MIGHT INCREASE THE RISK OF IMPLANT FRACTURE IN ONE LOT WHERE THE SUPPLIER ERROR OCCURRED.
Description of Event or Problem
PATIENT REPORTED MEDIAL KNEE PAIN. FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED ON X-RAY. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.
Remedial action
- Recall