BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSENSUS HIP SYSTEM

    MDR report key: 377253 · Received February 12, 2002

    Report

    Report Number
    2952369-2002-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2002
    Date of Event
    January 30, 2002
    Report Date
    February 12, 2002
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    X-RAYS OF A PATIENT REVEALED A BROKEN FEMORAL STEM. THE FEMUR WAS FOUND TO BE UNDAMAGED AFTER BREAKAGE OF THE FEMORAL STEM. A REVISION SURGERY WAS PERFORMED 2002 TO REPLACE THE DAMAGED COMPONENT. DURING THE REVISION SURGERY THE ORIGINAL BIPOLAR COMPONENTS WERE ALSO REPLACED WITH A FULL ACETABULAR HIP SYSTEM. THE STEM HAD BEEN IMPLANTED FOR APPROXIMATELY 1.25 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSENSUS HIP SYSTEM FEMORAL STEM, NONPOROUS, SIZE 8 KWY HAYES MEDICAL, INC. NA 170470

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R 1.BIPOLAR HEAD, 2.BIPOLAR INSERT, 3.FEMORAL HEAD.