BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS MOD. TIB. TRAY

    MDR report key: 3939014 · Received July 16, 2014

    Report

    Report Number
    0002249697-2014-02728
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: 6478-6-405, DCON P-FIT STEM COCR 16MMX80MM, FC1SDLZUJS; 6478-6-500, OFFSET ADAPTER 8MM, MAR330; 75-4-0310, SCORPIO TS 10MM FULL BLOCK, T05M1202; 6478-6-410, DCON P-FIT STEM COCR 17MMX80MM, LABOU; 73-3710, SCORPIO U-DOME PATELLA, Y233; 75-1-0315, SCORPIO TS DISTAL BLOCK, T05H760; 75-1-0315, SCORPIO TS DISTAL BLOCK, T05E339; 76-4103R, SCORPIO TS FEM. W/LFIT, K05C662; 6191-1-001, SIMPLEX P FULL DOSE 1 PACK, RIO204; 6197-9-001, SIMPLEX P WITH TOBRAMYCIN 1 PACK, MJO045. 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 TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A SCORPIO TS MOD. TIB. TRAY WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOTS REFERENCED. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS FURTHER INFORMATION IS NEEDED. 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.

    Description of Event or Problem · 1

    IMPLANTS WERE REMOVED DUE TO INFECTION.

    Description of Event or Problem · 1

    IMPLANTS WERE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416409 SCORPIO TS MOD. TIB. TRAY IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH A1XMEA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention