BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISYN HIP SYSTEM

    MDR report key: 550141 · Received April 13, 2004

    Report

    Report Number
    2952369-2004-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2004
    Date of Event
    March 16, 2004
    Report Date
    April 12, 2004
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    LWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED BROKEN FEMORAL HIP STEM. A REIVISON SURGERY IS SCHEDULED TO REPLACE THE BROKEN COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISYN HIP SYSTEM HIP PROSTHESIS - FEMORAL STEM LWJ HAYES MEDICAL, INC. NA 470493

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R FEMORAL HEAD, ACETABULAR SHELL & INSERT.| NECK COMPONENT, BODY COMPONENT, LOCKING NUT