BEUDAMED
    FDA Adverse Event Other Summary report: N

    15CC HYDROSET INJECTABLE CEMENT

    MDR report key: 1993465 · Received February 11, 2011

    Report

    Report Number
    8010177-2011-00044
    Event Type
    Other
    Date Received
    February 11, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE FAILURE IS ATTRIBUTED TO A MISUSE OF THE USER. THE DURABILITY OF HYDROSET WAS EXPIRED AND THE LABEL OUTSIDE OF THE BOX WAS READABLE. THEREFORE, NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    PER CUSTOMER, EXPIRED HYDROSET WAS USED IN A RECENT CASE AND IS STILL IN PATIENT'S SKULL. SALES REP WAS NOT IN CASE WHEN PROCEDURE WAS DONE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15CC HYDROSET INJECTABLE CEMENT IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA IC00484

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK