BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 23607462 · Received November 20, 2025

    Report

    Report Number
    3008274656-2025-00010
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005801
    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

    BLOOD CULTURE AT THE TIME OF WASHOUT WAS POSITIVE FOR INFECTION AND A SUBSEQUENT CULTURE WAS NEGATIVE. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. PRIOR TO EVENT, PATIENT WAS REPORTED TO HAVE AN ORAL/GUM ULCER. THERE IS NO INFORMATION TO SUGGEST THAT THE INFECTION WAS CAUSED BY THE MISHA PRODUCT; THE SOURCE OF THE POST-OPERATIVE INFECTION REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ABOUT 2.5 MONTHS AFTER MISHA IMPLANTATION, THE PATIENT RECEIVED A WASHOUT DUE TO A SUSPECTED INFECTION. A PICC LINE WAS STARTED FOR ANTIBIOTICS AFTER WHICH THE PATIENT WAS REPORTED DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263114 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV QVV MOXIMED, INC. 25042201 00856047005801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention