BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS

    MDR report key: 2030024 · Received March 25, 2011

    Report

    Report Number
    1043534-2011-00092
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 28, 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
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED AND ADDITIONAL DATA RECEIVED (B)(4) 2011:CATALOG NUMBER 38AM-4235, LOT NUMBER 068625242.DEVICE MANUFACTURER DATE 06/27/2008. (B)(4)

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED. (B)(4) - EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED, UNDETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE #3:INVESTIGATION IS NOT COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00090, 00091.

    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 HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 068625242

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R