BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIRALLOY CERAMIC FEMORAL HEAD, BIOPRO

    MDR report key: 65876 · Received January 27, 1997

    Report

    Report Number
    1833506-1997-00001
    Event Type
    Injury
    Date Received
    January 27, 1997
    Date of Event
    December 30, 1996
    Report Date
    January 24, 1997
    Manufacturer
    BIOPRO, CIV IF IMT
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CERAMIC FEMORAL HEAD BROKE IN PT DUE TO A FALL. PT HAS A HISTORY OF FALLING FREQUENTLY DUE TO BEING EPILEPTIC. REVISION SURGERY TO REPLACE CERAMIC FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIRALLOY CERAMIC FEMORAL HEAD, BIOPRO Implant 28 MM MEDIUM NECK FEMORAL HEAD. KWY BIOPRO, CIV IF IMT * 91-0831

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R