BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE(TM) TIBIAL TRAY

    MDR report key: 2243383 · Received September 12, 2011

    Report

    Report Number
    1043534-2011-00542
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    PMA / PMN Number
    K051023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #6: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00537, 00538, 00539, 00540, 00541, 00543, 00544.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. MANUFACTURING RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL ACCEPTANCE/INSPECTION CRITERIA. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION OF THE BONE AND SURROUNDING TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INBONE(TM) TIBIAL TRAY SMALL JOINT COMPONENT HSN WRIGHT MEDICAL TECHNOLOGY, INC. 021159615

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R