BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS, INC.

    MDR report key: 619144 · Received June 23, 2005

    Report

    Report Number
    619144
    Event Type
    Injury
    Date Received
    June 23, 2005
    Date of Event
    April 12, 2005
    Report Date
    June 8, 2005
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD TOTAL HIP REPLACEMENT LEFT IN 1991, REVISION IN 2003. THE PT HAS DISLOCATED TWICE AND HAS BEEN UNSTABLE. THE PT IS DISLOCATING ANTERIORLY. THEY WERE ADMITTED FOR A TOTAL LEFT HIP ARTHROPLASTY. DURING THE PROCEDURE THE HEAD COMPONENT AND THE LINER COMPONENT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS, INC. OFFSET MODULAR HEAD COMPONENT JDI BIOMET, INC. * 922730
    2 BIOMET ORTHOPEDICS, INC. MODULAR ACETABULAR LINER LPH BIOMET * 405170

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R