BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCORPIO PS TIB INSERT

    MDR report key: 1008596 · Received March 4, 2008

    Report

    Report Number
    2249697-2008-00056
    Event Type
    Death
    Date Received
    March 4, 2008
    Date of Event
    September 1, 2007
    Report Date
    February 5, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STUDY SITE REPORTED A COMPLICATION OF CARDIOPULMONARY ARREST IN A STUDY PT. THE CIRCUMSTANCES SURROUNDING THE ONSET OF THE COMPLICATION WAS "PATIENT PRESENTED WITH KNEE PAIN AND UNDERWENT I&D. IN THE EVENING OF SURGERY, PT SUFFERED ARREST" AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS TIB INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA 81877901

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R