BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS LV+G BONE CEMENT

    MDR report key: 1478924 · Received July 10, 2009

    Report

    Report Number
    1822565-2009-00757
    Event Type
    Malfunction
    Date Received
    July 10, 2009
    Date of Event
    May 26, 2009
    Report Date
    May 28, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS BONE CEMENT IS MFG AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. A SAMPLE OF CEMENT FROM THE LOT IN QUESTION WAS TESTED AT THE SUPPLIER AND THE WORKING PROPERTIES OF THE CEMENT WERE FOUND TO BE WITHIN RANGE SPEC. ADDITIONALLY, THIS PARTICULAR LOT DOES NOT EXPIRE UNTIL APRIL, 2011. CHANGES IN TEMPERATURE OF THE ROOM, CEMENT COMPONENTS, PROSTHESIS, OR MIXING VESSEL, AS WELL AS VARIANCES IN HUMIDITY OR MIXING TECHNIQUE, COULD HAVE SLIGHTLY ALTERED THE CURING PROPERTIES. WITHOUT FURTHER SURGICAL DETAIL, HOWEVER, AN EXACT CAUSE OF FAILURE COULDN'T BE DETERMINED. THE ALLEGED FAILURE COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS DELAYED 45 MINUTES AFTER THE BONE CEMENT FAILED TO SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS LV+G BONE CEMENT BONE CEMENT LOD ZIMMER, INC. NA 65714104

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR