BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDROSET INJECTABLE CEMENT KIT 10CC

    MDR report key: 2223818 · Received August 18, 2011

    Report

    Report Number
    8010177-2011-00246
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 26, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, THE CUSTOMER DISCOVERED PARTICLES IN THE CEMENT POWDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROSET INJECTABLE CEMENT KIT 10CC IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA IC01017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK