BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) DOUBLE HIGH TIBIAL INSERT

    MDR report key: 2830895 · Received November 13, 2012

    Report

    Report Number
    1043534-2012-01534
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 15, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 1043534-2012-01535.

    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. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN - LOOSE. PHYSICIAN NOTED EVIDENCE OF METAL WEAR. LOW ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) DOUBLE HIGH TIBIAL INSERT KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 114122581

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention