BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DURACON KNEE

    MDR report key: 2915546 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90105
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    September 11, 2001
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH AN ATTORNEY FROM THE PT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE DURACON KNEE IMPLANTED ON (B)(6) 2001 FAILED AND WAS REMOVED ON (B)(6) 2007."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13504 UNKNOWN DURACON KNEE IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R