BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRS 15X127 CURVED FEMORAL STEM

    MDR report key: 1629303 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00278
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    March 6, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDICS
    Product Code
    KRO
    PMA / PMN Number
    K952970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 3 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DIMENSIONAL DISCREPANCY) AND PRODUCT CODE KRO.

    Description of Event or Problem · 1

    DIMENSIONAL DISCREPANCY. IT WAS REPORTED THAT, "IMPLANT CURVATURE WAS LESS BOWED THAN TRIAL STEM. AS FEMUR WAS REAMED WITH FLEXIBLE REAMER AND THE FEMUR IS BOWED, THE LESS BOWED STEM IMPLANT CANNOT BE INSERTED. THE FEMUR HAD TO BE OVER REAMED BY 2MM TO ACCOMMODATE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRS 15X127 CURVED FEMORAL STEM IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDICS NA RYNMMA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other