BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM CUP

    MDR report key: 2211488 · Received August 9, 2011

    Report

    Report Number
    MW5021707
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 7, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BIOMET ORTHOPEDICS INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PRESENTS WITH NEED FOR HIP REVISION DUE TO PAIN AND SQUEAKING REPORTED FROM PREVIOUS BIOMET IMPLANT. SHE HAS A LONG STANDING HISTORY OF RHEUMATOID ARTHRITIS. DURING THE PROCEDURE, THE SURGEON'S ATTEMPTS TO DISENGAGE THE TAPER ADAPTER FROM THE FEMORAL STEM WERE UNSUCCESSFUL. THE TAPER ADAPTER WAS CUT FROM THE STEM USING A COMPETITOR'S INSTRUMENT. WE ARE REPORTING THIS ITEM DUE TO A NOTED SMALL TREND IN REVISION'S NEEDED IN YOUNGER, MORE ACTIVE PTS. METAL LEVELS WERE DETECTED IN THE PT. OF CONCERN IS THE INABILITY TO DISENGAGE THE TAPER ADAPTER AS WELL. TYPICAL THERAPY FOR POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM CUP HIP ARTHROPLASTY IMPLANTS KWA BIOMET ORTHOPEDICS INC US157852 669720
    2 TAPER ADAPTER HIP ARTHROPLASTY IMPLANTS JDI BIOMET ORTHOPEDICS INC. 139254 389960
    3 MODULAR HEAD 45MM HIP ARTHROPLASTY IMPLANTS LPH BIOMET ORTHOPEDICS INC. 157446 409780
    4 TAPERLOC STEM HIP ARTHROPLASTY IMPLANTS MEH BIOMET ORTHOPEDICS INC. 103206 247180

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention