BEUDAMED
    FDA Adverse Event Other Summary report: N

    5CC HYDROSET INJECTABLE CEMENT

    MDR report key: 2823783 · Received July 30, 2008

    Report

    Report Number
    8010177-2008-00048
    Event Type
    Other
    Date Received
    July 30, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 30, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    GXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HYDROSET 5CC. WED. CASE WAS ORIGINAL SURGERY. ON FRIDAY HAS TO GO IN AND DO A REVISION SURGERY AND NOTICED HYDROSET WAS CRACKED AND CRUMBLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5CC HYDROSET INJECTABLE CEMENT IMPLANT GXP STRYKER OSTEOSYNTHESIS FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention