BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE HFX SIZE #3

    MDR report key: 1621889 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00977
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    October 21, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWL
    PMA / PMN Number
    K922146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE ARE 1 EVENTS ASSOCIATED WITH THIS EVENT TYPE (FOREIGN MATTER FOUND IN THE PACKAGE OR ON THE DEVICE) AND PRODUCT CODE KWL.

    Description of Event or Problem · 1

    FOREIGN MATTER FOUND IN PACKAGE OR ON THE DEVICE. IT WAS REPORTED THAT, "WHILE PERFORMING A HEMIARTHROPLASTY, OUR ACCOLADE HFX STEM #3 WAS REQUESTED AND WAS OPENED. UPON ACCEPTING THE STEM AND IMPACTOR FROM HER SCRUB TECH, THE DOCTOR NOTICED A DEFECT/CORROSION ON THE BOTTOM EDGE OF THE STEM'S TRUNNION. SHE DECIDED NOT TO IMPLANT THE STEM AND REQUESTED ANOTHER #3 STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE HFX SIZE #3 IMPLANT KWL STRYKER ORTHOPAEDICS NA H3NMMD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other