BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 23595603 · Received November 19, 2025

    Report

    Report Number
    3008274656-2025-00007
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    September 2, 2024
    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

    THE MISHA REMOVAL WAS COMPLETED WITHOUT COMPLICATION. THE PATHOLOGY REPORT WAS CONSISTENT WITH SUTURE ABSCESS AND LOCALIZED, SUPERFICIAL INFECTION. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. 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 HAD MISHA IMPLANTATION FOR OA AND 42 DAYS LATER UNDERWENT IRRIGATION AND DEBRIDEMENT DUE TO SUSPECTED SUTURE ABSCESS WITH REMOVAL OF THE PROXIMAL-MOST SCREW. ANOTHER 10 DAYS LATER, THE PATIENT UNDERWENT A REPEAT IRRIGATION AND DEBRIDEMENT WITH DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389542 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV QVV MOXIMED, INC. 23092503 00856047005801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention