BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED FLUTED TIBIAL PLATE

    MDR report key: 4092227 · Received August 20, 2014

    Report

    Report Number
    1822565-2014-01000
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500644 NEXGEN STEMMED FLUTED TIBIAL PLATE JWH ZIMMER INC 60861947

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention MANUFACTURED AT (B)(4) AND| DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL| PRODUCTS.| PALACOS R BONE CEMENT, CATALOG #00111214001| LOT# 66184139, QTY 2 - THIS BONE CEMENT IS