BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 9MM

    MDR report key: 3198772 · Received July 1, 2013

    Report

    Report Number
    0002249697-2013-02195
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT:CAT 5555-4600, LOT 060912-04, DESCRIPTION: TRIATHLON PRECISION TIBIAL SIZER KIT;CAT 5555-4205, LOT 080311-03, DESCRIPTION: TRIATHLON CR PRECISION FEMORAL PREP KIT SIZE 5;CAT 5555-3205, LOT 100511-03, DESCRIPTION: TRIATHLON CR PRECISION TIBIAL PREP KIT STD SIZE 5;CAT 5517-F-502, LOT S7LXP, DESCRIPTION: TRIATHLON P/A CR BEADED #5R;CAT 5520-B-500, LOT S9KSY, DESCRIPTION: TRIATHLON PRIM CEM FXD BPLT #5.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW DETERMINED THAT THE LOT AND STERILE LOT WERE MANUFACTURED AND PACKED TO SPECIFICATION. COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN NO SIMILAR EVENTS FOR THE LOT OR STERILE LOT. THE EXACT CAUSE OF THE REPORTED INFECTION COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE REPORTED DEVICE, X-RAYS, OPERATIVE REPORTS, MEDICAL RECORDS INCLUDING PATIENT HISTORY, FOLLOW-UP NOTES AND PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING 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

    IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME INFECTED, SO THE SURGEON REVISED THE POLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME INFECTED SO THE SURGEON REVISED THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299619 X3 TRIATHLON CS INSERT #5 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCF709

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention