BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10EDG X3 INSERT 36MM ID

    MDR report key: 1621887 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00975
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    February 12, 2008
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (FOREIGN MATTER FOUND IN THE PACKAGE OR ON THE DEVICE) AND PRODUCT CODE JDI.

    Description of Event or Problem · 1

    FOREIGN MATTER FOUND IN PACKAGE OR ON THE DEVICE. IT WAS REPORTED THAT "SURGEON PERFORMING TOTAL HIP ARTHROPLASTY. REQUESTED LINER OPENED UNTO STERILE FIELD BY OPERATING ROOM - RN. DOCTOR NOTICED A PARTICLE OF DEBRIS ON LINER BEFORE IMPLANTING INTO THE PT. HE REQUESTED AN ADDITIONAL LINER BE OPENED WHICH WE HAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10EDG X3 INSERT 36MM ID IMPLANT JDI STRYKER ORTHOPAEDICS NA N5YMJD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other