BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISYN HIP SYSTEM

    MDR report key: 550211 · Received August 11, 2004

    Report

    Report Number
    MW1032979
    Event Type
    Injury
    Date Received
    August 11, 2004
    Date of Event
    March 8, 2004
    Report Date
    August 11, 2004
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT HAD BEEN IMPLANTED WITH A RIGHT FEMORAL PROSTHETIC ON 2002. IN 2004, THE SUBJECT RIGHT FEMORAL PROSTHETIC INEXPLICABLY FAILED, THAT IS, THE SHAFT OF THE PROSTHETIC DEVICE FRACTURED. IN 2004, THE PT UNDERWENT A TOTAL RIGHT HIP REVISION WITH EXCHANGE OF FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISYN HIP SYSTEM RIGHT FEMORAL PROSTHETIC JDI HAYES MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| S