BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R BONE CEMENT

    MDR report key: 2860167 · Received November 21, 2012

    Report

    Report Number
    1822565-2012-02388
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE HOSPITAL STAFF DEEMED THE PRODUCT NON-STERILE AND WOULD NOT USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R BONE CEMENT BONE CEMENT LOD ZIMMER, INC. 74574300

    Patients

    Seq Age Sex Outcome Treatment
    1