BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM DISTAL CENTRALIZER

    MDR report key: 2891483 · Received December 6, 2012

    Report

    Report Number
    1822565-2012-02496
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WHEN THE NURSE OPENED THE STERILE PACKAGE THE DISTAL CENTRALIZER WAS NOT IN PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM DISTAL CENTRALIZER LWJ ZIMMER, INC. 62132681

    Patients

    Seq Age Sex Outcome Treatment
    1