BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG X3 INSERT 36MM ID

    MDR report key: 1621891 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00979
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 27, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORHTOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 MEH.

    Description of Event or Problem · 1

    FOREIGN MATTER FOUND IN PACKAGE OR ON THE DEVICE. IT WAS REPORTED: "AS THE DOCTOR WAS ABOUT TO IMPLANT THE ACETABULAR LINER, HE DISCOVERED A HAIR ON THE LINER. THE DOCTOR REMOVED THE IMPLANT FROM THE FIELD AND HAD ANOTHER ONE OPENED AND IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG X3 INSERT 36MM ID IMPLANT MEH STRYKER ORHTOPAEDICS NA 26122401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other