BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) POSTERIOR STABILIZED TIBIAL INSERT

    MDR report key: 1932477 · Received December 18, 2010

    Report

    Report Number
    1043534-2010-00552
    Event Type
    Injury
    Date Received
    December 18, 2010
    Date of Event
    November 25, 2009
    Report Date
    July 26, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K972626
    Adverse Event
    Yes
    Product Problem
    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. THE PATIENT AND USER FACILITY INFORMATION WERE NOT PROVIDED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00551. THIS EVENT OCCURRED IN THE (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. ANALYSIS SHOWS NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY PER (B)(4), THE PATIENT WAS REVISED DUE TO UNKNOWN PROBLEMS.

    Description of Event or Problem · 1

    ALLEGEDLY PER (B)(6), THE COMPONENT WAS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) POSTERIOR STABILIZED TIBIAL INSERT KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R