BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY UNI TIBINRT S1-2RM/LL8MM

    MDR report key: 6137829 · Received December 1, 2016

    Report

    Report Number
    1020279-2016-00923
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 15, 2016
    Report Date
    February 19, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSX
    PMA / PMN Number
    K061011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS COMMUNICATED THAT EXPLANT WILL NOT BE AVAILABLE FOR INVESTIGATION UNTIL 6 MONTHS PAST THE SURGERY DUE TO LOCAL REGULATIONS.

    Additional Manufacturer Narrative · 1

    NEW EVALUATION SUMMARY SUPPLEMENTS PREVIOUSLY COMMUNICATED EVALUATION SUMMARY.IT WAS FURTHER COMMUNICATED THAT HOSPITAL RETENTION OF EXPLANTS PER LOCAL REGULATION IS 3 YEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT REVISION SURGERY OCCURRED DUE TO POSSIBLE DISLOCATION WHICH WAS NOTICED 3 DAYS AFTER THE INITIAL SURGERY BY THE CLICKING SOUND AND X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789172 JOURNEY UNI TIBINRT S1-2RM/LL8MM PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX SMITH & NEPHEW, INC. 16CM14702

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R