BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 46MM O.D.

    MDR report key: 2163579 · Received July 12, 2011

    Report

    Report Number
    MW5021322
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    April 6, 2011
    Report Date
    June 27, 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 UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2011, DUE TO PAIN. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 46MM O.D. MODULAR HEAD KWA BIOMET ORTHOPEDICS 157446 UNKNOWN
    2 UNKNOWN M2A MAGNUM TAPER ADAPTER TAPER ADAPTER KWA BIOMET ORTHOPEDICS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention