BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNASTY

    MDR report key: 2683598 · Received July 23, 2012

    Report

    Report Number
    2683598
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 23, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXPLANTATION OF WRIGHT MEDICAL TECHNOLOGY 8 DEGREE SHORT VARUS MODULAR NECK, AND 32 MM WRIGHT MEDICAL TECHNOLOGY COBALT CHROME FEMORAL HEAD WITH 0MM NECK EXTENSION. REMOVAL OF GROUP C COBALT CHROME ACETABULAR POROUS-COATED MODULAR ACETABULAR COMPONENT. DEVICE EXPLANTED RELATED TO (AVAL) ACUTE LYMPHOCYTIC VASCULITIS AND ASSOCIATED LESIONS METAL IONS RELEASED FROM METAL-ON METAL HIP REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNASTY HIP PROSTHESIS KWA WRIGHT MEDICAL TECHNOLOGY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR