BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 2178382 · Received July 26, 2011

    Report

    Report Number
    1043534-2011-00354
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 7, 2011
    Report Date
    January 16, 2012
    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

    DEVICE #2: CORRECTED DATA RECEIVED 1/16/2012: REVISION DATE - (B)(6) 2011. APPOX AGE OF DEVICE - 4 MONTHS. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE #2: 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 1043534-2011-00353. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE #2: CORRECTED DATA RECEIVED 11/02/2011: LOT NUMBER - 0701165733. EXPIRATION DATE - 07/31/2018. IMPLANTED DATE - (B)(6) 2010. APPRPX AGE OF DEVICE - 5 MONTHS. MANUFACTURER DATE - 07/30/2010. ADDITIONAL INFORMATION RECEIVED 11/02/2011: AN ADDITIONAL DEVICE WAS RETURNED; THEREFORE, THIS IS THE SAME EVENT AS 1043534-2011-00354, 000630. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    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. 0701165733

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R