BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 232272 · Received July 16, 1999

    Report

    Report Number
    1020279-1999-00017
    Event Type
    Injury
    Date Received
    July 16, 1999
    Date of Event
    April 14, 1999
    Report Date
    July 15, 1999
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE DISASSOCIATION OF A FEMORAL HEAD FROM A TAPERED FEMORAL C0MPONENT. THE DEVICE WAS IMPLANTED ON 3/31/1999. THE PT STARTED PARTIAL WEIGHT BEARING ON 4/8/1999. THE DR DISCOVERED THE DISASSOCIATION OF THE HEAD FROM THE FEMORAL COMPOENENT WHILE VIEWING AN X-RAY ON OR AROUND 4/14/1999. THE REVISION SURGERY WAS PERFORMED ON 4/14/1999. ONLY THE FEMORAL HEAD AND BIPOLAR WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA Implant FEMORAL HEAD KWY SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION NA 80400159

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention