BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A MAGNUM PF CUP

    MDR report key: 2028435 · Received March 21, 2011

    Report

    Report Number
    MW5019899
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 11, 2011
    Manufacturer
    BIOMET
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMET HIP JOINT REQUIRED REPLACEMENT IMPLANTED (B)(6), 2009 AND REPLACED (B)(6) 2011 FOR METALLOSIS, LACK OF BONE INGROWTH AND NOTE OF TISSUE REACTION M2A MAGNUM PF CUP/M2A MODULAR HEAD/M2A MAGNUM TAPER ADAPTER. PART (B)(6). LOT NUMBER 669160/911160/248250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP IMPLANTABLE HIP JOINT KWA BIOMET US157858 669160
    2 M2A MODULAR HEAD IMPLANTABLE HIP JOINT KWA BIOMET 157452 911160
    3 M2A MAGNUM TAPER ADAPTER IMPLANTABLE HIP JOINT KWY BIOMET 139264 248250

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR