BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 647408 · Received November 18, 2005

    Report

    Report Number
    1822565-2005-00219
    Event Type
    Injury
    Date Received
    November 18, 2005
    Date of Event
    August 12, 2005
    Report Date
    October 28, 2005
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED ON AUGUST 19, 2002. IN 2005, THE SURGEON NOTED ON THE X-RAY THAT OSTEOLYTIC LESIONS OR CYST HAD FORMED AROUND THE THREADS AND TIP OF THE SCREWS USED TO AFFIX THE PLATE. THE PLATE ITSELF WAS NOT LOOSE. THE DEVICE WAS REVISED ON OCTOBER 24, 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER, INC. NA 1428071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R