BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER DOUGH-TYPE BONE CEMENT 40GM/20ML

    MDR report key: 3070588 · Received April 17, 2013

    Report

    Report Number
    1526350-2013-00189
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MFR, IT WAS DISCARDED BY THE HOSPITAL. THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE AMPOULE IN THE MONOMER WAS ALREADY BROKEN. IT WAS REPORTED THAT THE SURGEON USED AN ALTERNATIVE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166525 ZIMMER DOUGH-TYPE BONE CEMENT 40GM/20ML ZIMMER DOUGH-TYPE BONE CEMENT 40GM/20ML LOD ZIMMER SURGICAL NA 77001677

    Patients

    Seq Age Sex Outcome Treatment
    1