MISHA KNEE SYSTEM
Received Nov 19, 2025 · Event occurred Nov 18, 2024
Report 3008274656-2025-00009 · MDR key 23596128
Device
Generic name
Medial Knee Implanted Shock Absorber, Product Code: Qvv
Manufacturer
Moximed, Inc.Catalog number
2-1001
Lot number
23092102
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Loss of Range of Motion
- Loss of Range of Motion
Narrative
Additional Manufacturer Narrative
THE MISHA REMOVAL WAS COMPLETED WITHOUT COMPLICATION. ANALYSIS OF THE RETURNED DEVICE FOUND IT TO BE INTACT AND WELL-FUNCTIONING. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. AT THE TIME OF MISHA IMPLANTATION, ADDITIONAL PROCEDURES OF ARTHROSCOPIC MEDIAL MENISCECTOMY AND CHONDROPLASTY OF THE PATELLA AND LATERAL TIBIAL PLATEAU WERE PERFORMED AND SOME LOSS OF MOTION PRIOR TO THE MISHA PROCEDURE WAS NOTED. THE CAUSE OF THE EVENT REMAINS UNKNOWN. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS AND ANY REQUIRED MDR REPORTING.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT MISHA IMPLANTATION FOR OA ALONG WITH ARTHROSCOPIC MEDIAL MENISCECTOMY AND CHONDROPLASTY OF THE PATELLA AND LATERAL TIBIAL PLATEAU WITH SOME LOSS OF MOTION PRIOR TO THE MISHA PROCEDURE. MORE THAN 6 MONTHS LATER, THE PATIENT EXPERIENCED LOSS OF MOTION AND UNDERWENT ARTHROSCOPIC DEBRIDEMENT, ANTERIOR AND POSTERIOR CAPSULE RELEASE REGAINING RANGE OF MOTION. THE PATIENT EXPERIENCED LOSS OF MOTION AGAIN AND UNDERWENT MISHA REMOVAL AND FULL RANGE OF MOTION WAS NOTED.