BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 52MM X 46MM

    MDR report key: 1070705 · Received June 26, 2008

    Report

    Report Number
    1070705
    Event Type
    Injury
    Date Received
    June 26, 2008
    Date of Event
    March 12, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BIOMET ORTHOPEDICS INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HIP REPLACEMENT WITH A METAL ON METAL PROSTHESIS AND NO SURGICAL COMPLICATIONS. THERE WERE NO PROBLEMS INITIALLY, BUT EVENTUALLY THE PROSTHESIS STARTED MAKING A LOUD AUDIBLE CLUNKING OR GRINDING NOISE. PATIENT OPTED FOR REVISION, AND IT WAS SURGICALLY EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP 52MM X 46MM PROSTHESIS, HIP, METAL JDI BIOMET ORTHOPEDICS INC. US157852 906530
    2 M2A MAGNUM MODULAR HEAD 46MM PROSTHESIS, HIP, METAL JDI BIOMET ORTHOPEDICS INC. 157446 137410

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R