BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM

    MDR report key: 7442898 · Received April 19, 2018

    Report

    Report Number
    0001825034-2018-02875
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    June 12, 2017
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: S061140 SELEX/MAGNUM MOD HD 40MM -6 830220, 11-104106 MLRY-HD POR FMRL 6X135MM 605260. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 BY PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY TEN YEARS AGO. SUBSEQUENTLY, LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE, DUE TO METALLOSIS, EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD, FLUID IN AND AROUND THE HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288165 M2A MAGNUM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 482300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R