BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP FEMORAL STEM

    MDR report key: 178149 · Received July 21, 1998

    Report

    Report Number
    1644408-1998-00001
    Event Type
    Other
    Date Received
    July 21, 1998
    Date of Event
    April 29, 1998
    Report Date
    July 20, 1998
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXTENDED SURGICAL TIME REQUIRED DUE TO BREAKAGE OF INSERTER INSTRUMENT IN IMPLANT. IMPLANT (HIP STEM) WAS REMOVED AND ANOTHER IMPLANT WAS SUCCESSFULLY IMPLANTED. (INSTRUMENT COVERED UNDER SEPARATE MDR.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP FEMORAL STEM Implant FEMORAL HIP STEM LPH ENCORE ORTHOPEDICS, INC. * 301371

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other