BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN RHK FEMORAL COMPONENT

    MDR report key: 3022660 · Received March 22, 2013

    Report

    Report Number
    1822565-2013-00518
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THE PATIENT WAS REVISED DUE TO FRACTURE OF THE STEM HOUSING IN THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120812 NEXGEN RHK FEMORAL COMPONENT KRO ZIMMER, INC. 60163664

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention