BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 4223299 · Received October 29, 2014

    Report

    Report Number
    3007963827-2014-00057
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    July 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691488 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER 62079828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AT ZIMMER (B)(4).| NEXGEN STEMMED TIBIAL COMPONENT,| CATALOG #00598004701, LOT #62099375, MANUFACTURED