BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3875209 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02302
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON PS X3 TIBIAL INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED. 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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT NO.: 5550-G-360, TRIATHLON SYMMETRIC X3 PATELLA, LOT CODE: T7J3; CAT NO.: 5515-F-501, TRIATHLON PS FEM COMPONENT, CEMENTED, LOT CODE: HXAXA; CAT NO.: 5520-M-600, TRIATHLON MIS BASEPLATE #6, LOT CODE: ECB8C. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    DUE TO INFECTION THE LISTED IMPLANTS WERE REMOVED.

    Description of Event or Problem · 1

    DUE TO INFECTION THE LISTED IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352268 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLT7LA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention