BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 1251298 · Received December 4, 2008

    Report

    Report Number
    1043534-2008-00354
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 1, 2008
    Report Date
    December 3, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-2008-00353. THIS EVENT OCCURRED IN ANOTHER COUNTRY. THE FOLLOWING DATES ARE ESTIMATED. ONLY THE MONTH/YEAR IS KNOWN: DATE OF EVENT. IMPLANT DATE. EXPLANT DATE. AWARE OF EVENT.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR MODULAR FEMORAL NECK LWJ WRIGHT MEDICAL TECHNOLOGY, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R