BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 FEM HEAD ORTHINOX 26+4

    MDR report key: 1629290 · Received February 5, 2010

    Report

    Report Number
    9610669-2009-00070
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    September 28, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A.
    Product Code
    LZO
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 3 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DAMAGED STERILE PACKAGE) AND PRODUCT CODE (LZO).

    Description of Event or Problem · 1

    DAMAGED STERILE PACKAGE. THE CUSTOMER REPORTED VIA THE TM THAT AS THE HEAD WAS ABOUT TO BE IMPLANTED, THE SURGEON NOTICED THAT PART OF THE PLASTIC PACKAGING WAS STUCK TO THE DEVICE. IT WAS FURTHER REPORTED THAT ANOTHER HEAD WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 FEM HEAD ORTHINOX 26+4 IMPLANT LZO STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A. NA GA686095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other