BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 21752756 · Received April 2, 2025

    Report

    Report Number
    3008274656-2025-00003
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 4, 2025
    Report Date
    June 16, 2025
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005795
    PMA / PMN Number
    DEN220033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AVAILABLE POST-OPERATIVE RADIOGRAPHS INDICATE THAT THE FEMORAL BASE WAS MALPOSITIONED AT TIME OF IMPLANTATION, INDICATIVE OF INTRAOPERATIVE USER ERROR. THE RETRIEVAL ANALYSIS IDENTIFIED IMPINGEMENT MARKS ON THE PISTON NECK AND FEMORAL SOCKET CONFIRMING MALPOSITIONING OF THE FEMORAL BASE RELATIVE TO THE ABSORBER. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE FRACTURED COMPONENT CONFORMED TO MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    A DEVICE REMOVAL IS PLANNED. IF/WHEN EXPLANTED, RETURNED, AND THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    FRACTURE AT THE FEMORAL END OF THE ABSORBER WAS OBSERVED ON X-RAY AT ANNUAL DOCTOR'S VISIT. PATIENT COMMENTED ON TENDERNESS AROUND THE IMPLANT. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.

    Description of Event or Problem · 0

    FRACTURE AT THE FEMORAL END OF THE ABSORBER WAS OBSERVED ON X-RAY AT ANNUAL DOCTOR'S VISIT. PATIENT COMMENTED ON TENDERNESS AROUND THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302735 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER QVV MOXIMED, INC. 23032901 00856047005795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female