BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER KINECTIV MODULAR NECK

    MDR report key: 3102108 · Received April 26, 2013

    Report

    Report Number
    1822565-2013-00713
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 PT WAS REVISED POSSIBLY DUE TO AN ALLERGIC REACTION TO THE METAL ION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182249 ZIMMER KINECTIV MODULAR NECK KWA ZIMMER, INC. 61550335

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention LOT#61473719| TRILOGY SHELL WITH CLUSTER HOLES: CAT#00620005422,| THE FOLLOWING WERE MFG BY ZIMMER (B)(4)| VERSYS FEMORAL HEAD: CAT#00801803602, LOT#61558102