BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 5323644 · Received December 23, 2015

    Report

    Report Number
    3007963827-2015-00046
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 4, 2015
    Manufacturer
    ZIMMER, BUILDING #2
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). OTHER DEVICES USED: CATALOG #00593203210, NEXGEN PROLONG ARTICULAR SURFACE, LOT #62058801; MANUFACTURED AT ZIMMER B.V., (B)(4). CATALOG #00598003702, NEXGEN STEMMED TIBIAL COMPONENT, LOT #62249953; MANUFACTURED AT ZIMMER B.V., (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO A PAINFUL AND STIFF KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848252 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH JWH ZIMMER, BUILDING #2 62201757

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention