BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP

    MDR report key: 2030864 · Received March 23, 2011

    Report

    Report Number
    MW5019933
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    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

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6)-2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6)-2011 DUE TO SIGNS OF METALLOSIS AND LACK OF BONE INGROWTH. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE ALL REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP ACETABULAR CUP KWA BIOMET ORTHOPEDICS US157858 590810
    2 MODULAR HEAD MODULAR HEAD JDI BIOMET ORTHOPEDICS 157452 648880
    3 TAPER ADAPTER TAPER ADAPTER JDI BIOMET ORTHOPEDICS 139264 496030

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention