BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5CC HYDROSET INJECTABLE CEMENT

    MDR report key: 2467333 · Received February 17, 2012

    Report

    Report Number
    8010177-2012-00036
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND OPENING OF THE STERILE HYDROSET PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5CC HYDROSET INJECTABLE CEMENT IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA M55S1 IC01035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK