BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II TIBIAL BASE

    MDR report key: 2942244 · Received February 4, 2013

    Report

    Report Number
    1043534-2013-00193
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    July 11, 2011
    Report Date
    October 22, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 1043534-2013-00192, 00194. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45794 ADVANCE(R) II TIBIAL BASE KNEE COMPONENT, CODE:HRY HRY WRIGHT MEDICAL TECHNOLOGY, INC. 096378600

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention