BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINECTIVE TECHNOLOGY NECK PROVISIONAL

    MDR report key: 1073698 · Received July 1, 2008

    Report

    Report Number
    1822565-2008-00375
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE PRODUCT WAS REMOVED AFTER TRIAL REDUCTION THE BOTTOM PORTION WAS MISSING AND UNABLE TO BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINECTIVE TECHNOLOGY NECK PROVISIONAL HIP INSTRUMENT LXH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR