BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    MDR report key: 2143460 · Received June 29, 2011

    Report

    Report Number
    1043534-2011-00304
    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
    JWH
    PMA / PMN Number
    K972626
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #2: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. 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 1043534-2011-00303.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND PHOTOGRAPHIC IMAGES WERE MADE. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED; NO EVIDENCE OF MISUSE.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    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. 018530731

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R