BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II TRADITIONAL TIBIAL INSERT

    MDR report key: 2830715 · Received November 13, 2012

    Report

    Report Number
    1043534-2012-01532
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. PHOTOGRAPHIC IMAGES WERE MADE. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    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.

    Description of Event or Problem · 1

    ALLEGEDLY PRIMARY BILATERAL PATELLA RESURFACING WAS DONE WITH COMPETITOR'S METAL BACKED PRESS FIT PATELLA. WHILE RESURFACING THE PATELLAS, IT WAS DECIDED THAT THE INSERT NEEDED TO BE REVISED FROM A 10MM TO 12MM THICKNESS IN ORDER TO BALANCE THE KNEE BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) II TRADITIONAL TIBIAL INSERT KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 124133332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention