BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AA

    MDR report key: 1013340 · Received March 13, 2008

    Report

    Report Number
    1822565-2008-00100
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DEVICE REVISED, HAS BEEN REVISED DUE TO LOOSENING. EXACT IMPLANT AND EXPLANT DATES ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AA HIP PROSTHESIS KWB ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R