BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    MDR report key: 1932298 · Received December 17, 2010

    Report

    Report Number
    1043534-2010-00538
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    June 10, 2010
    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 1043534-2010-00536, 00537. THIS EVENT OCCURRED IN THE (B)(6).

    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)(6) OF (B)(6), THE PATIENT WAS REVISED DUE TO UNKNOWN PROBLEMS.

    Description of Event or Problem · 1

    ALLEGEDLY PER (B)(6), THE PATIENT WAS REVISED DUE TO UNKNOWN PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R