BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO-FLEX PS X3 TIB INSERT

    MDR report key: 1132043 · Received August 21, 2008

    Report

    Report Number
    2249697-2008-00237
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 28, 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 NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; 'THE PATIENT WHO GOT THE REVISION SURGERY IN 2008, VISITED HOSPITAL AGAIN DUE TO PAIN. SURGEON FOUND OUT THAT THE INSERT POST WAS BROKEN AND REPLACED TO NEW INSERT. THIS PATIENT'S PRIMARY SURGERY WAS DONE EIGHT MONTHS LATER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX PS X3 TIB INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA 560MAD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention