BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS MOD. TIB. TRAY

    MDR report key: 2170055 · Received July 13, 2011

    Report

    Report Number
    2249697-2011-01048
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K032479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT WAS REVISED BECAUSE OF PAIN. HIS PLAIN X-RAYS, INCLUDING AP, LATERAL AND SUNRISE VIEWS, SHOW WHAT APPEARS TO BE A LOOSE TIBIAL COMPONENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TS MOD. TIB. TRAY IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MJD5M3

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention