MISHA KNEE SYSTEM
Received Nov 19, 2025 · Event occurred Jul 5, 2024
Report 3008274656-2025-00005 · MDR key 23594916
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 · Female
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT MISHA IMPLANTATION FOR OA ALONG WITH A PARTIAL MENISCECTOMY. FIVE DAYS LATER, THE PATIENT PRESENTED WITH PUS AT THE WOUND AND RECEIVED A WASHOUT AND ANTIBIOTICS. FIFTEEN DAYS AFTER IMPLANTATION, THE DEVICE WAS REMOVED.
Additional Manufacturer Narrative
THE MISHA REMOVAL WAS COMPLETED WITHOUT COMPLICATION. AT THE TIME OF DEVICE REMOVAL, WOUND CULTURES WERE NEGATIVE FOR INFECTION. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. AT THE TIME OF MISHA IMPLANTATION, A PARTIAL MENISCECTOMY WAS ALSO 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.