BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #6 11MM

    MDR report key: 4093804 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03494
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN NUMBER 6 X 11 INSERT. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON CS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED RELEVANT DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO REPORTED SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE LIMITED INFORMATION PROVIDED. IT WAS REPORTED THAT A 11 MM THICK CS INSERT WAS REVISED TO A 16MM THICK CS INSERT DUE TO INSTABILITY. FURTHER INFORMATION SUCH AS DEVICE RETURN, X-RAYS, PRIMARY AND REVISION OPERATIVE NOTES AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INSTABILITY MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE POLY EXCHANGE DUE TO INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE POLY EXCHANGE DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572837 X3 TRIATHLON CS INSERT #6 11MM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH LDC245

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R