BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIFIT HFX HIP STEM SIZE #08 132

    MDR report key: 1621848 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00943
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    March 22, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K031744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 4 EVENTS ASSOCIATED WITH THIS EVENT TYPE (COMPROMISED STERILE PACKAGE (BLISTER OR LID)) AND PRODUCT CODE JDI.

    Description of Event or Problem · 1

    COMPROMISED STERILE PACKAGE (BLISTER OR LID). IT WAS REPORTED THAT, "WHEN DOCTOR ASKED FOR STEM TO IMPLANT, THE BOX WAS OPENED AND TOP COVER WAS PEELED BACK. SECOND STERILE COVER WAS NOT ON PLASTIC COVER AND IMPLANT WAS EXPOSED. STEM WAS NOT IMPLANTED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT HFX HIP STEM SIZE #08 132 IMPLANT JDI STRYKER ORTHOPAEDICS NA 2Y8MAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other