BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 21283985 · Received January 31, 2025

    Report

    Report Number
    3008274656-2025-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 3, 2025
    Report Date
    May 2, 2025
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005795
    PMA / PMN Number
    DEN220033
    Removal / Correction Number
    3008274656/12022024/R/00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MOXIMED HAS REQUESTED THE DEVICE FOR EVALUATION BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY SIGNIFICANT NEW INFORMATION IS OBTAINED.THE ROOT CAUSE IS A SUPPLIER ERROR. AN INCORRECT DRILL WAS USED RESULTING IN AN INACCURATE DRILL POINT ANGLE AND REDUCED MATERIAL THICKNESS. THIS MIGHT INCREASE THE RISK OF IMPLANT FRACTURE IN ONE LOT WHERE THE SUPPLIER ERROR OCCURRED.

    Additional Manufacturer Narrative · 0

    THE FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS CONFIRMED ON ANALYSIS OF THE DEVICE. THE ROOT CAUSE IS A SUPPLIER ERROR. AN INCORRECT DRILL WAS USED RESULTING IN AN INACCURATE DRILL POINT ANGLE AND REDUCED MATERIAL THICKNESS. THIS MIGHT INCREASE THE RISK OF IMPLANT FRACTURE IN ONE LOT WHERE THE SUPPLIER ERROR OCCURRED.

    Description of Event or Problem · 0

    FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED ON X-RAY. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455994 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER QVV MOXIMED, INC. 23032901 00856047005795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male