BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 890023 · Received August 2, 2007

    Report

    Report Number
    1822565-2007-00257
    Event Type
    Injury
    Date Received
    August 2, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 6, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004. THE DEVICE WAS REVISED IN 2007, DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER ANATOMIC CC FEM STEM COL PRCT KWY ZIMMER, INC. NA 61928400

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R