BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER(R) ADVANTIM(R) POST STAB LSI TIBIAL INSERT

    MDR report key: 3250438 · Received July 26, 2013

    Report

    Report Number
    1043534-2013-01198
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE 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 REVISED FOR UNKNOWN REASONS AT THIS TIME. DOCTOR THOUGHT EITHER THE WEAR ON THE TIBIAL BASE PLATE FROM THE DISTAL FEMUR OR SOFT TISSUE HAD PREVENTED THE NEW INSERT FROM LOCKING PROPERLY INTO THE OLD BASE PLATE. HE REVISED WITH THE SAME SIZE INSERT AND USED SOME CEMENT ANTERIORLY ON THE BASE PLATE TO HELP HOLD THE INSERT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349653 DURAMER(R) ADVANTIM(R) POST STAB LSI TIBIAL INSERT KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 099A12834801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention