BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS DIST FEM COMP STD L 65MM

    MDR report key: 1620592 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00289
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 4, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDICS
    Product Code
    KRO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (POST OPERATIVE ADVERSE RESULT) AND PRODUCT CODE KRO.

    Description of Event or Problem · 1

    POST OPERATIVE ADVERSE RESULT. IT WAS REPORTED, "A DISTAL FEMUR FRACTURE IN A PATIENT WITH A PREVIOUS COMPETITOR'S IMPLANT WAS VERY FRAGMENTED. THE SURGEON ELECTED TO USE GMRS PROSTHESIS. THE SURGERY WENT WITHOUT EVENT. THE SURGEON LATER INFORMED ME THAT THE PATIENT POSTOPERATIVELY WAS DIAGNOSED WITH A FOOTDROP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMRS DIST FEM COMP STD L 65MM IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDICS NA L7XNA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other| R