BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 4252934 · Received November 12, 2014

    Report

    Report Number
    1822565-2014-01564
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 3, 2012
    Report Date
    October 13, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729563 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT JWH ZIMMER, INC. 61367785

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention