BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ARTICULAR SURFACE

    MDR report key: 2153280 · Received June 30, 2011

    Report

    Report Number
    1822565-2011-01547
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ARTICULAR SURFACE JWH ZIMMER, INC. 6081058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #60811486| NEXGEN FEMORAL COMPONENT: CAT #00541601602| LOT #60819475| NEXGEN STEMMED TIBIAL COMPONENT: CAT #630701210| PALACOS BONE CEMENT: CAT #00111214001| LOT #60841120| LOT #65624131| NEXGEN ALL POLY PATELLA: CAT #00542000802| MANUFACTURED BY HEREAUS MEDICAL