BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3944088 · Received July 18, 2014

    Report

    Report Number
    0002249697-2014-02794
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED DOCTOR SUSPECTED INFECTION, SO PATIENT WAS BROUGHT TO OR FOR A WASH OUT. DOCTOR DID A REVISION OF RIGHT KNEE AND REMOVED INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED DOCTOR SUSPECTED INFECTION, SO PATIENT WAS BROUGHT TO OPERATING ROOM FOR A WASH OUT. DOCTOR DID A REVISION OF RIGHT KNEE AND REMOVED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422263 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMTKP6

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention