BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 2255912 · Received September 20, 2011

    Report

    Report Number
    1043534-2011-00554
    Event Type
    Injury
    Date Received
    September 20, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 18, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE.

    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 1043534-2011-0000555, 00556. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT FELT PAIN AND SURGEON CONFIRMED PSEUDOTUMOR SO REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 088673571

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R