BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM

    MDR report key: 4241439 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04218
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION WILL NOT BE MADE AVAILABLE EITHER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A WASHOUT DONE ON RIGHT KNEE FOR INFECTION. SURGEON REVISED AND REMOVED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722239 NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention