BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 20641246 · Received November 8, 2024

    Report

    Report Number
    3008274656-2024-00003
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005801
    PMA / PMN Number
    DEN220033
    Removal / Correction Number
    3008274656/12022024/R000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED DURING THE DEVICE REMOVAL AND CONFIRMED ON INITIAL 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.

    Additional Manufacturer Narrative · 0

    THE FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED DURING THE DEVICE REMOVAL AND CONFIRMED ON INITIAL ANALYSIS OF THE DEVICE. THE INVESTIGATION INTO THE ROOT CAUSE IS ONGOING, INCLUDING METALLURGICAL ANALYSIS. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PATIENT HAD MISHA KNEE SYSTEM IMPLANTATION WITH CONCOMITANT POSTERIOR MEDIAL MENISCAL ROOT TEAR REPAIR. PATIENT EXPERIENCED ONGOING PREDOMINANTLY FEMORAL KNEE PAIN. THE PATIENT UNDERWENT CHONDROPLASTY, LYSIS OF ADHESIONS, AND DEVICE REMOVAL. DURING THE DEVICE REMOVAL, THE TIBIAL END OF THE ABSORBER WAS NOTED TO HAVE A FRACTURE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951920 MISHA KNEE SYSTEM IMPLANTED SHOCK ABSORBER QVV MOXIMED, INC. 23032901 00856047005801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male POSTERIOR MEDIAL MENISCUS ROOT REPAIR.