BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G BONE CEMENT

    MDR report key: 2799949 · Received October 17, 2012

    Report

    Report Number
    1822565-2012-02105
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDICS SURGICAL PRODUCTS. EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVALUATION: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER , INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE AMPULE OF MONOMER WAS BROKEN WHEN THE BONE CEMENT BOX WAS OPENED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R+G BONE CEMENT BONE CEMENT LOD ZIMMER INC 74614301

    Patients

    Seq Age Sex Outcome Treatment
    1