BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II TIBIAL BASE

    MDR report key: 2143435 · Received June 29, 2011

    Report

    Report Number
    1043534-2011-00303
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 25, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRY
    PMA / PMN Number
    K960617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 018533926. PHOTOGRAPHIC IMAGES WERE MADE. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED. UNDETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00304.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) II TIBIAL BASE KNEE COMPONENT HRY WRIGHT MEDICAL TECHNOLOGY, INC. 018533926

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R