BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-6

    MDR report key: 8744456 · Received June 28, 2019

    Report

    Report Number
    0001825034-2019-02820
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    March 28, 2016
    Report Date
    June 28, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: M2A-MAGNUM PF CUP 64ODX58ID # ITEM US157864 LOT 792860. M2A-MAGNUM MOD HD SZ 58MM # ITEM 157458 LOT 832880. TAPERLOC POR RED/LAT 17.5X155 # ITEM 13-103209 LOT 479640. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES PROVIDED. REVISION OP NOTES DATED WERE REVIEWED AND IDENTIFIED PATIENT WAS REVISED DUE TO PAIN. DURING THE REVISION, IT WAS IDENTIFIED FEMORAL HEAD COULD NOT BE DISASSOCIATED FROM THE STEM WITH NOTED TRUNNIONNOSIS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND ELEVATED METAL IONS. THE SURGEON FOUND IRRITATIVE JOINT FLUID WITHIN THE CAPSULE WHEN THEY OPENED THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538659 M2A-MAGNUM 52-60MM TPR INSRT-6 PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 348620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R