BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R BONE CEMENT

    MDR report key: 2181099 · Received July 22, 2011

    Report

    Report Number
    1822565-2011-01707
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    December 6, 2007
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BONE CEMENT IS MFG AT HERAEUS MED 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 THE PT WAS REVISED DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R BONE CEMENT BONE CEMENT LOD ZIMMER, INC. 63123888

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention