BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 13MM

    MDR report key: 3233682 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02372
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    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

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 7650-2038A, LOT RD7W124A, DESCRIPTION: STERILE FLUTED HEADLESS 1/8" PIN 3.5"LONG; CAT 5510-F-502, LOT EB88K, DESCRIPTION: TRIATHLON CR FEM COMP #5 R-CEM; CAT 5521-B-500, LOT HTXW, DESCRIPTION: TRI TS BASEPLATE SIZE5; CAT 5551-G-350, LOT R61J, 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON X3 INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT 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 INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL.

    Description of Event or Problem · 1

    KNEE I & D AND LINER EXCHANGE. KNEE DRAINAGE.

    Description of Event or Problem · 1

    KNEE I&D AND LINER EXCHANGE. KNEE DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336108 X3 TRIATHLON CS INSERT #5 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCX398

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R