BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABLIZED LPS-FLEX ARTICULAR

    MDR report key: 1082144 · Received July 25, 2008

    Report

    Report Number
    1822565-2008-00452
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAUSE CANNOT BE DEFINITIVELY DETERMINED. SLIGHT BURNISHING MARKS WERE OBSERVED ALONG THE SURFACE AND BACKSIDE OF THE DEVICE. IT COULD NOT BE DETERMINED IF THESE SCRATCHES ORIGINATED FROM MANUFACTURING OF THE DEVICE OR POSSIBLE INSERTION ATTEMPT. THE EDGES OF THE BURNISHING MARKS COULD NOT BE FELT AND THE WHITE POWDER REPORTED FROM POSSIBLE SCRATCH DEBRIS WAS NOT OBSERVED DURING EVALUATION. THE DEVICE MEETS INSPECTION SPECIFICATION IN ITS RETURNED CONDITION AND IS CONSIDERED ACCEPTABLE. THE MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE REMAINING LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY IN 2008, THE SURGEON NOTICED A SCRATCH AND WHITE POWDER ON THE ARTICULAR SURFACE IMPLANT PRIOR TO INSERTING THE DEVICE ON THE TIBIAL PLATE IMPLANT. HE REQUESTED A NEW ARTICULAR SURFACE OPENED AND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABLIZED LPS-FLEX ARTICULAR KNEE PROSTHESIS JWH ZIMMER, INC. NA 60455293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK