BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 4093888 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03503
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 10, 2013
    Report Date
    August 7, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED BY THE ATTORNEY. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIATHLON KNEE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PLAINTIFF CONTINUES TO SUFFER FROM PAIN AND COMPLICATIONS WITH PLAINTIFF'S RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571191 TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C MBH STRYKER ORTHOPAEDICS-MAHWAH MLJVW3

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R