BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN KNEE LPS-FLEX FEMORAL COMPONENT

    MDR report key: 3113703 · Received May 10, 2013

    Report

    Report Number
    1822565-2013-00783
    Event Type
    Injury
    Date Received
    May 10, 2013
    Report Date
    April 11, 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 BY THE PT THAT THE PT RECEIVED AN IMPLANT IN (B)(6) 2008 AND IS EXPERIENCING PAIN, STIFFNESS, LABORED WALKING, INSTABILITY, AND THE KNEE GIVING OUT. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205253 NEXGEN KNEE LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 60480941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG #00598003702, LOT #60798593| (B)(4):| NEXGEN STEMMED TIBIAL COMPONENT:| CATALOG #00596403014, LOT #60634411| NEXGEN ALL POLY PAELLA: CATALOG #00597206532,| LOT #60850918| THE FOLLOWING WERE MANUFACTURED IN ZIMMER (B)(4)| NEXGEN LPS-FLEX ARTICULAR SURFACE:| NEXGEN TAPER PLUG: CATALOG #00596009900,| LOT #60668675