BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 9MM

    MDR report key: 4243448 · Received November 11, 2014

    Report

    Report Number
    0002249697-2014-04238
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON CS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN AS WELL AS OPERATIVE NOTES, PATIENT HISTORY, FOLLOW-UP NOTES AND PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL. ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 5510F602, LOT # EJ3RM, DESCRIPTION: TRIATHLON CR FEM COMP #6 R-CEM; CAT # 5520B500, LOT # EJ7NM, DESCRIPTION: TRIATHLON PRIM CEM FXD BPLT #5; CAT # 5551-G-350, LOT # D0P0, DESCRIPTION: TRIATHLON ASYMMETRIC X3 PATELLA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. THE LOT CODE PROVIDED, LTY561, IS INVALID. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED ON RIGHT KNEE DUE TO INFECTION. DOCTOR DID AN I & D, INSERT EXCHANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED ON RIGHT KNEE DUE TO INFECTION. DOCTOR DID AN I & D, INSERT EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726316 X3 TRIATHLON CS INSERT #5 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCY561

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R