BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-6

    MDR report key: 8603675 · Received May 13, 2019

    Report

    Report Number
    0001825034-2019-02174
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    March 28, 2016
    Report Date
    May 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. REVISION OP NOTES WERE REVIEWED AND PATIENT WAS REVISED DUE TO COMPLICATIONS OF PAIN AND ELEVATED ION LEVELS. DURING THE REVISION SURGERY IT WAS IDENTIFIED STEM WAS UNABLE TO DISENGAGE FROM THE TAPER. AN OSTEOTOMY WAS DONE TO REMOVE THE STEM. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM MOD HD SZ 58MM # ITEM 157458 LOT 832880, M2A-MAGNUM PF CUP 64ODX58ID # ITEM US157864 LOT 792860, TAPERLOC POR RED/LAT 17.5X155 # ITEM 13-103209 LOT 479640. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02175. 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 WAS BEING REVISED APPROXIMATELY SEVEN YEARS POST INITIAL SURGERY DUE TO PAIN. DURING REVISION, THE FEMORAL HEAD COULD NOT BE DISASSOCIATED FROM THE STEM WITH NOTED TRUNNIONOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397041 M2A-MAGNUM 52-60MM TPR INSRT-6 PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 348620

    Patients

    Seq Age Sex Outcome Treatment
    1