BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE POSTS W/LEFT

    MDR report key: 1620547 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00940
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    September 25, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STYRKER ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, (B) (4) CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO (B) (4) 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 3 EVENTS ASSOCIATED WITH THIS EVENT TYPE (USER RELATED) AND PRODUCT CODE JWH.

    Description of Event or Problem · 1

    USER RELATED. IT WAS REPORTED THAT LEFT FEMORAL COMPONENT WAS IMPLANTED IN A PT'S RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE POSTS W/LEFT IMPLANT JWH STYRKER ORTHOPAEDICS NA K03E1108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other