BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2113470 · Received May 31, 2011

    Report

    Report Number
    1822565-2011-01287
    Event Type
    Injury
    Date Received
    May 31, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 IS REPORTED THAT THE PT EXPERIENCED A BURNING SENSATION IN THE KNEE WHILE UNDERGOING AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT NONE JWH ZIMMER INC 60672087

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG # 00598604702, LOT# 60674851| MANUFACTURED ZIMMER (B)(4)| NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT