BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R BONE CEMENT

    MDR report key: 2781951 · Received October 5, 2012

    Report

    Report Number
    1822565-2012-02046
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INSTRUCTIONS FOR USE RECOMMEND SPECIAL PRECAUTIONS SHOULD BE TAKEN. THE LIQUID MONOMER IS HIGHLY VOLATILE AND FLAMMABLE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A SMALL FLAME APPEARED IN THE MIDDLE OF THE BONE CEMENT FOR APPROXIMATELY TWO SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R BONE CEMENT BONE CEMENT LOD ZIMMER, INC. 74424287

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR