BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A MAGNUM 42-50M TPR INSRT +6

    MDR report key: 6876399 · Received September 19, 2017

    Report

    Report Number
    0001825034-2017-07177
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 28, 2017
    Report Date
    September 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM PF CUP 48ODX42ID P/N US157848 L/N 907610 M2A-MAGNUM MOD HD SZ 42MM P/N 157442 L/N 275210 BI-METRIC/X POR NC 9X125 P/N X180309 L/N 678520.

    Description of Event or Problem · 1

    REPORTED SURGEON HAD DIFFICULTY GETTING THE MODULAR HEAD FROM THE MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655353 M2A MAGNUM 42-50M TPR INSRT +6 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 908310

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR