BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3222455 · Received July 12, 2013

    Report

    Report Number
    0002249697-2013-02269
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFICS ARE AVAILABLE REGARDING THE PATIENTS OR THE CIRCUMSTANCES. NO FURTHER INFORMATION WAS RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    BONE JOINT J. 2013 MAY;95-B(5):636-42. - GØTHESEN O ET AL - SURVIVAL RATES AND CAUSES OF REVISION IN CEMENTED PRIMARY TOTAL KNEE REPLACEMENT: A REPORT FROM THE (B)(4) ARTHROPLASTY REGISTER 1994-2009 - (B)(4) NJR DATA SUGGESTS THAT THE RELATIVE REVISION RISK DUE TO ASEPTIC TIBIAL FIXATION FAILURE FOR THE FIXED MODULAR BEARING DURACON TOTAL KNEE DEVICE IS 4.5 COMPARED TO THAT OF THE REFERENCE DEVICE. THE PAPER STATES, "THE INFERIOR RESULTS REPORTED HERE FOR THE DURACON TKR DIFFER FROM THOSE REPORTED FROM THE (B)(4) ARTHROPLASTY REGISTER. A POSSIBLE EXPLANATION COULD BE THAT IN 2005 THE DURACON TKR WAS INTRODUCED IN ONE GEOGRAPHIC REGION OF NORWAY AS A RESULT OF A TENDER PROCESS, AND THEREFORE THE LOCAL SURGEONS WERE OBLIGED TO GO THROUGH A LEARNING PROCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322593 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other