BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO-FLEX PS X3 TIB INSERT

    MDR report key: 1233919 · Received November 14, 2008

    Report

    Report Number
    2249697-2008-00365
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K051977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFO, HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THIS PATIENT GOT THE PRIMARY TKR SURGERY IN 2008, SUDDENLY GOT A FEELING OF WEAKNESS ON KNEE AND VISITED HOSPITAL AGAIN. SURGEON CHECKED THE INSTABILITY ON KNEE AND CONDUCTED REVISION SURGERY, AND FOUND OUT THE BROKEN LINER POST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX PS X3 TIB INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA E18MAE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention