BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) TOT COND FEMORAL NON-POROUS

    MDR report key: 2942246 · Received February 4, 2013

    Report

    Report Number
    1043534-2013-00192
    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
    JWH
    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 1043534-2013-00193, 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
    46845 ADVANCE(R) TOT COND FEMORAL NON-POROUS KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 096378828

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention