BEUDAMED
    FDA Adverse Event Summary report: N

    M2A MAGNUM(TM) MODULAR HEAD

    MDR report key: 1070583 · Received June 27, 2008

    Report

    Report Number
    1070583
    Date Received
    June 27, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BIOMET ORTHOPEDICS,INC.
    Product Code
    JDI
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMET REPRESENTATIVE HAD INCORRECT COMPONENT (56MM HEAD). THIS WAS DISCOVERED AFTER THE SURGERY WAS COMPLETED. PATIENT/FAMILY INFORMED AND PATIENT RETURNED TO OR TO HAVE CORRECT HEAD PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM(TM) MODULAR HEAD PROSTHESIS, HIP, METAL JDI BIOMET ORTHOPEDICS,INC. * 343950

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR