BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN NP STRAIGHT FEMORAL STEM

    MDR report key: 662908 · Received January 9, 2006

    Report

    Report Number
    1043534-2006-00005
    Event Type
    Other
    Date Received
    January 9, 2006
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY THE STEM BROKE AND NEEDED TO BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN NP STRAIGHT FEMORAL STEM HIP COMPONENT KWY WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention