BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 2033940 · Received March 18, 2011

    Report

    Report Number
    2249697-2011-00336
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    July 28, 2010
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PER BECAME LEGAL MATTER. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. THE DEVICE AND ADDITIONAL FOLLOW-UP INFO WAS REQUESTED BY STRYKER ORTHOPAEDICS' LEGAL AFFAIRS DEPARTMENT. SHOULD DEVICE OR ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ATTORNEY FOR THE PT CALLED ASKING IF THE EXPLANTED TRIATHLON INSERT WAS RECALLED. THE REVISION WAS PERFORMED DUE TO PAIN AND HIS KNEE BUCKLING TO THE INSIDE. COULDN'T WALK ON IT OR PERFORM REGULAR DAILY ACTIVITIES. NEEDED A CANE TO WALK. AS PER ATTORNEY, DR'S REPORT STATES "FAILED IMPLANT". ATTORNEY IS IN POSSESSION OF THE EXPLANTED INSERT FOR EVALUATION. SINCE THE REVISION (REPLACED THE POLY INSERT) THE PT IS DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 37588901

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention