BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G BONE CEMENT

    MDR report key: 2400080 · Received December 2, 2011

    Report

    Report Number
    1822565-2011-02667
    Event Type
    Malfunction
    Date Received
    December 2, 2011
    Date of Event
    October 3, 2011
    Report Date
    November 4, 2011
    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 BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING, THE POWDER PACKAGE WAS DEEMED NOT STERILE DUE TO HOW PACKAGING RIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R+G BONE CEMENT BONE CEMENT LOD ZIMMER, INC. 71714254

    Patients

    Seq Age Sex Outcome Treatment
    1