BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3082973 · Received April 29, 2013

    Report

    Report Number
    0002249697-2013-01470
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AND RESULTS: PHOTOGRAPHS OF THE DEVICE WERE RECEIVED. DAMAGE WAS NOTED ON THE INSERT. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. 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.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 5515-F-501, TRIATHLON PS FEM COMPONENT, CEMENTED, LOT CODE: ADPA. CAT. NO.: 5520-B-400, TRIATHLON PRIM TIB BASEPLATE, CEMENTED, LOT CODE: BRNI. CAT. NO.: 5551-G-320, TRIATHLON ASYMMETRIC X3 PATELLA, LOT CODE: 819R. AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 1.0 Y. THE TIBIAL INSERT, TIBIA TRAY , FEMORAL CONDYLE AND PATELLAR COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 6 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 7.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 1.0 Y. THE TIBIAL INSERT, TIBIA TRAY , FEMORAL CONDYLE AND PATELLAR COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 6 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185927 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKH6AV

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention