BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS FEMORAL

    MDR report key: 1834320 · Received September 14, 2010

    Report

    Report Number
    1043534-2010-00376
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    February 1, 2009
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    NXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00375.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, REVISED DUE TO INFECTION.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS FEMORAL HIP COMPONENT NXT WRIGHT MEDICAL TECHNOLOGY, INC. 101A147210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R