BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5CC HYDROSET INJECTABLE CEMENT

    MDR report key: 2043389 · Received February 25, 2011

    Report

    Report Number
    8010177-2011-00055
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. INTERNAL INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING MVD PROCEDURE, AND 3CC OF HYDROSET CRACKED AND CRUMBLED UPON SET UP. THE SALES REP WAS NOT THERE DURING THE CASE. HE WAS CONTACTED BY FACILITY AFTER THE PROCEDURE TO LET HIM KNOW. THE SURGEON WAS ABLE TO REMOVE THE OLD PRODUCT AND USE NEW. THE PROCEDURE WORKED WELL THE SECOND TIME. THE EXPIRATION DATE OF THE HYDROSET IS 08/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5CC HYDROSET INJECTABLE CEMENT IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA IC00873HG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK