BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED PRECOAT TIBIAL COMPONENT

    MDR report key: 4112858 · Received September 17, 2014

    Report

    Report Number
    2648920-2014-00242
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    December 13, 2012
    Report Date
    August 19, 2014
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576107 NEXGEN STEMMED PRECOAT TIBIAL COMPONENT JWH ZIMMER MANUFACTURING B.V. 60642287

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention