BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1414024 · Received July 15, 2009

    Report

    Report Number
    1020279-2009-00631
    Event Type
    Injury
    Date Received
    July 15, 2009
    Report Date
    June 15, 2009
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISLOCATION OCCURRED WHEN TRAILING CAUSING THE TRIAL LINER FELL INTO THE WOUND. THIS EXTENDED SURGERY TIME TWO HOURS WHILE SEARCHING FOR THE TRIAL LINE. THE SURGEON COMPLETED SURGERY WITHOUT RETRIEVING THE LINER. NO PLANS FOR REMOVAL ODF TRIAL HEAD HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI TRIAL FEMORAL HEAD/EIY KWY BROOKS MANUFACTURING SITE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R