BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 3781381 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01577
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON CR X3 TIBIAL INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. 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 NO MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS X-RAY IMAGES, OPERATIVE REPORTS, AND PATIENT FOLLOW-UP NOTES ARE NEEDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    LEFT KNEE REVISION DUE TO INSTABILITY IN FLEXION. THE SURGEON REMOVED THE INSERT AND REVISED TO A THICKER INSERT, 5530-G-513 MKK8Y9.

    Description of Event or Problem · 1

    LEFT KNEE REVISION DUE TO INSTABILITY IN FLEXION. THE SURGEON REMOVED THE INSERT AND REVISED TO A THICKER INSERT, 5530-G-513 MKK8Y9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260666 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLJH7X

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention