BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK

    MDR report key: 1620557 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00665
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    August 21, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS
    Product Code
    KWY
    PMA / PMN Number
    K023901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORP 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 9 EVENTS ASSOCIATED WITH THIS EVENT TYPE (INCORRECT INSTRUCTIONS PROVIDED AND PRODUCT CODE JDI).

    Description of Event or Problem · 1

    INCORRECT INSTRUCTIONS PROVIDED. THE SALES REP REPORTED THAT THE SURGEON IMPLANTED A V40 ALUMINA FEMORAL HEAD WITH THE (B) (4) FEMORAL COMPONENT. IT SEEMS THAT THE HOSPITAL MAY HAVE USED THIS SAME COMBINATION IN PREVIOUS SURGERIES SINCE 2006. ON THE LITERATURE FOR THE (B) (4) PRODUCT, (B) (4), IT STATES THAT (B) (4) SYSTEM CAN BE USED ALL V40 HEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK IMPLANT KWY STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS NA 22487001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other