BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING WRIGHT

    MDR report key: 104871 · Received July 9, 1997

    Report

    Report Number
    104871
    Event Type
    Injury
    Date Received
    July 9, 1997
    Date of Event
    June 1, 1997
    Report Date
    June 13, 1997
    Manufacturer
    DOW CORNING WRIGHT
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STATUS POST LEFT TOTAL HIP ARTHROPLASTY WITH LONG INTRAMEDULLARY COMPONENT 1/95. 6/1/97 DIAGNOSED WITH FRACTURE OF THE STEM OF THE IMPLANT JUST BELOW ITS COLLAR. IMPLANT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING WRIGHT Implant FEMORAL PROSTHESES JDI DOW CORNING WRIGHT * 044M343330
    2 DOW CORNING WRIGHT Implant FEMORAL PROSTHESES JDI DOW CORNING WRIGHT * 014M001577
    3 DOW CORNING WRIGHT Implant FEMORAL PROSTHESES JDI DOW CORNING WRIGHT * 014M000191
    4 DOW CORNING WRIGHT Implant FEMORAL PROSTHESES JDI DOW CORNING WRIGHT * 113M896850
    5 DOW CORNING WRIGHT Implant FEMORAL PROSTHESES JDI DOW CORNING WRIGHT * 024A000783

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R