BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #3 13MM

    MDR report key: 3870260 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02204
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICES WERE RETAINED AT DREXEL IMPLANT RESEARCH CENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A X3 TRIATHLON CS INSERT #3 13MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. NO DEVICE RETURNED. PHOTO PROVIDED FOR ANALYSIS SHOWED SOME SCRATCHES ON SUPERIOR AND INFERIOR SURFACE OF THE INSERT. NO MEDICAL EVALUATION PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW. INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INSTABILITY MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND PAIN. THE TIBIAL INSERT WAS REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND PAIN. THE TIBIAL INSERT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346989 X3 TRIATHLON CS INSERT #3 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBT836

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention