BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 23594916 · Received November 19, 2025

    Report

    Report Number
    3008274656-2025-00005
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    July 5, 2024
    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

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235936 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV QVV MOXIMED, INC. 23092102 00856047005795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention