BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIGHT MEDICAL PROFEMUR Z, MODULAR NECK

    MDR report key: 2264097 · Received September 19, 2011

    Report

    Report Number
    MW5022343
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    June 16, 2010
    Report Date
    September 19, 2011
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A TOTAL HIP REPLACEMENT WITH WRIGHT MEDICAL PROFEMUR Z MODULAR NECK SYSTEM ON (B)(6) 2008. ON THE DATE OF THE ADVERSE EVENT, THE PT FELT A POP AND IMMEDIATE PAIN IN THE HIP. THE FEMORAL NECK OF THE PROSTHESIS HAD FRACTURED. THE RESULT REQUIRED AN EXTENSIVE SURGERY TO OSTEOTOMIZE THE FEMUR AND REMOVE THE BROKEN PROSTHESIS AND REPLACE IT WITH A NEW ONE FROM A DIFFERENT MANUFACTURER. THE PT WILL HAD A LENGTHY CONVALESCENCE DUE TO THE REVISION OPERATION. REASON FOR USE: HIP OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT MEDICAL PROFEMUR Z, MODULAR NECK TOTAL HIP REPLACEMENT KWA WRIGHT MEDICAL PROFEMUR Z, MODULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability