BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUE TM SHELL WITH MULTI HOLES

    MDR report key: 4223330 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01472
    Event Type
    Injury
    Date Received
    October 29, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO RECURRING DISLOCATION. AFTER SURGERY, THE REMOVED NECK APPEARED TO HAVE A BLACK SUBSTANCE ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693126 CONTINUE TM SHELL WITH MULTI HOLES LZO ZIMMER, INC. 62687280

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR IMPLANTED| CATALOG #00784802001, LOT #62427927-RETURNED| KINECTIV TECHNOLOGY MODULAR NECK,| ON (B)(6) 2014| ZIMMER ML TAPER KINECTIVE STEM,| CATALOG #00771300600, LOT #62647150-REMAINS| CONTNUUM VIVACIT-E NEUTRAL LINER,| CATALOG #00885100932, LOT #62566762