BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 2940852 · Received June 28, 2006

    Report

    Report Number
    2940852
    Event Type
    Malfunction
    Date Received
    June 28, 2006
    Date of Event
    May 23, 2006
    Report Date
    June 27, 2006
    Manufacturer
    BIOMET
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT TOTAL HIP ARTHROPLASTY. DURING THE PROCEDURE, THE THREADED TIP OF METAL FRAME GAGE HANDLE WAS ATTACHED TO THE ACETABULAR IMPLANT AND FRACTURED DURING IMPACTION. THE THREADED TIP REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET METAL FRAME GAGE HANDLE LXH BIOMET 423598 897600

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other