BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 1629519 · Received March 5, 2010

    Report

    Report Number
    9616680-2009-00674
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    December 17, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K010757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 7/1/2006 TO 7/1/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (COMPROMISED STERILE PACKAGE, BLISTER, LID, OR FOREIGN MATERIAL AND PRODUCT CODE JDI).

    Description of Event or Problem · 1

    COMPROMISED STERILE PACKAGE (BLISTER, LID, OR FOREIGN MATERIAL). IT WAS REPORTED THAT "CIRCULATING NURSE OPENED IMPLANTS. SURGICAL TECH NOTICED INNER STERILE PACKAGE WAS BROKEN. NEW IMPLANT WAS GIVEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA AARMRD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other