BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PRECOAT STEMMED TIBIAL COMPONENT

    MDR report key: 3940599 · Received June 25, 2014

    Report

    Report Number
    2648920-2014-00162
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    December 27, 2011
    Report Date
    December 16, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MANUFACTURING REPORT NUMBER 1822565-2014-00068.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING. IT IS ALSO REPORTED THAT THE PATIENT UNDERWENT MANIPULATIONS ON (B)(6) 2009 AND (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369732 NEXGEN PRECOAT STEMMED TIBIAL COMPONENT JWH ZIMMER 61166811

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention