BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER COCR LFIT HEAD 36MM/0

    MDR report key: 1621865 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00956
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 8, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K910988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YR 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 (B) (4). THERE ARE 4 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED) AND PRODUCT CODE (B) (4).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED THAT "C-TAPER DID NOT FIT TRUNNION FOR AN EON STEM. WENT TO ANOTHER 36MM +0 C-TAPER WHICH FIT FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS NA 6HTMND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other