BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 3102128 · Received April 26, 2013

    Report

    Report Number
    1822565-2013-00711
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS EXPERIENCING KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181450 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 61311177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT#61251760, MFG AT ZIMMER (B)(4)| TIBIAL COMPONENT, LOT#61280955, MFG AT ZIMMER| CAT#00597206538, NEXGEN ALL POLY PATELLA,| (B)(4)| CAT #00598605701, NEXGEN STEMMED NONAUGMENTABLE| LOT#61281681| CAT#00596405010, NEXGEN LPS-FLEX ARTICULAR SURFACE