BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R BONE CEMENT

    MDR report key: 1202409 · Received October 17, 2008

    Report

    Report Number
    1822565-2008-00706
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BONE CEMENT IS MANUFACTURED AT FACILITY, AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. EVALUATION SUMMARY: BATCH 66644191, WHICH IS THE SUBJECT OF THE COMPLAINT, HAS BEEN CHECKED AGAINST THE RELEVANT PRODUCTION RECORD BY THE QUALITY CONTROL DEPARTMENT. THE CHECK SUGGESTED NO IRREGULARITIES WHATSOEVER. THE ABOVE-MENTIONED BATCH WAS PACKAGED ACCORDING TO SPECIFICATIONS. IN ORDER TO RULE OUT THE RISK OF A PRODUCT COMPONENT BEING MISSED, A SPECIAL CONTROL STATION DURING THE PACKAGING PROCESS IS PERFORMED AFTER EACH PRODUCTION JOB, AND IT IS DOCUMENTED ON A RECORD. THEREFORE, THE REASON FOR THE MISSING GLASS AMPULE IS NOT CLEAR. EVALUATION: DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE BOX OF PALACOS WAS OPENED, IT CONTAMINATED ONLY THE POWDER AND NO MONOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R BONE CEMENT BONE CEMENT LOD ZIMMER, INC. NA 66644191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK