BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON TS+ TIBIAL INSERT TRIAL #6 - 13MM

    MDR report key: 2931874 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00390
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    September 25, 2012
    Report Date
    January 16, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    MATERIAL ANALYSIS INDICATED THE TRIAL FRACTURED DUE TO MULTIPLE OVERLOAD CONDITIONS. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE INVESTIGATION CONCLUDED THAT THE CRACKED TRIAL WAS CAUSED BY MULTIPLE OVERLOAD CONDITIONS, WHICH IS MOST LIKELY DUE TO USER MISUSE AND/OR MALALIGNMENT DURING SEATING. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT KNEE TRIAL INSERT WAS FOUND TO HAVE A 2MM X 2MM CHIP AFTER THE TOTAL KNEE INCISION WAS PARTIALLY CLOSED. SITE EXPLORED AS WELL AS USE OF X-RAY AND FLUOROSCOPY TO VERIFY NO FOREIGN BODY LEFT IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT KNEE TRIAL INSERT WAS FOUND TO HAVE A 2MM X 2MM CHIP AFTER THE TOTAL KNEE INCISION WAS PARTIALLY CLOSED. SITE EXPLORED AS WELL AS USE OF X-RAY AND FLUOROSCOPY TO VERIFY NO FOREIGN BODY LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38126 TRIATHLON TS+ TIBIAL INSERT TRIAL #6 - 13MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH PPM3F48

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention