MISHA KNEE SYSTEM
Received Nov 19, 2025 · Event occurred Apr 15, 2025
Report 3008274656-2025-00008 · MDR key 23595823
Device
Generic name
Medial Knee Implanted Shock Absorber, Product Code: Qvv
Manufacturer
Moximed, Inc.Catalog number
2-1001
Lot number
25010305
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Additional Manufacturer Narrative
A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. AT THE TIME OF MISHA IMPLANTATION, ADDITIONAL PROCEDURES OF MEDIAL MENISCUS ROOT REPAIR AND SYNOVECTOMY WERE PERFORMED. THERE IS NO INFORMATION TO SUGGEST THAT THE INFECTION WAS CAUSED BY THE MISHA PRODUCT; THE SOURCE OF THE POST-OPERATIVE INFECTION 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 A MEDIAL MENISCUS ROOT REPAIR AND SYNOVECTOMY. ABOUT A MONTH LATER, THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT DUE TO REPORTED PAIN AND SWELLING. CULTURES FROM THE WOUND AND WERE CONSISTENT WITH METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). THREE DAYS LATER, A REPEAT IRRIGATION AND DEBRIDEMENT WITH DEVICE REMOVAL WAS PERFORMED. ABOUT A MONTH AFTER THE REMOVAL PROCEDURE, THE PATIENT WAS REPORTED DOING WELL.