BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 23595823 · Received November 19, 2025

    Report

    Report Number
    3008274656-2025-00008
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    April 15, 2025
    Report Date
    November 19, 2025
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005795
    PMA / PMN Number
    DEN220033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389544 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV QVV MOXIMED, INC. 25010305 00856047005795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention