BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM ONE BIPOLAR

    MDR report key: 2132591 · Received June 10, 2011

    Report

    Report Number
    2249697-2011-00862
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT THERE IS SIMILAR DEVICE COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT HAD A BHA IN 1996. HIS SYSTEM ONE BIPOLAR DISLOCATED DUE TO SOMETHING. THEREFORE, THE SURGEON TRIED TO REDUCE IT. HOWEVER, DURING THE CLOSED REDUCTION, THE INNER HEAD DISSOCIATED FROM THE SYSTEM ONE BIPOLAR." THE SURGEON REQUESTED A WEAR ANALYSIS AND A STATIC DISSOCIATION FORCE BETWEEN A SYSTEM ONE BIPOLAR AND AN INNER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM ONE BIPOLAR IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R