BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSENSUS HIP SYSTEM

    MDR report key: 298000 · Received September 22, 2000

    Report

    Report Number
    2952369-2000-00001
    Event Type
    Malfunction
    Date Received
    September 22, 2000
    Date of Event
    September 2, 2000
    Report Date
    September 22, 2000
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT FELL TO THE FLOOR, WHILE WALKING IMMEDIATELY AFTER LEAVING THE BED. A SUBSEQUENT X-RAY REVEALED A BROKEN FEMORAL STEM. REVISION SURGERY IS REQUIRED TO REMOVE THE IMPLANT AND REPLACE WITH A NEW ONE. THE DEVICE WAS IMPLANTED APPROXIMATELY THREE YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSENSUS HIP SYSTEM FEMORAL STEM, COLLARED, NONPOROUS, COCR KWY HAYES MEDICAL, INC. NA 170162B

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 1. ACETABULAR CUP,| 3. BONE SCREWS.| 2. FEMORAL HEAD,