BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM

    MDR report key: 4221384 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04106
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH INFECTED KNEE SO DOCTOR PERFORMED AN I&D AND REPLACED POLY. IT WAS A LEFT KNEE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH INFECTED KNEE SO DOCTOR PERFORMED AN I&D AND REPLACED POLY. IT WAS A LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701447 NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MHRD8R

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other