BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) TOT COND FEMORAL PC

    MDR report key: 4110319 · Received September 23, 2014

    Report

    Report Number
    3010536692-2014-01407
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE; REPORT WILL BE UPDATED WHEN COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT COMPLAINED OF CHRONIC PAIN. IT IS NOT KNOWN WHEN THE FRACTURE HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591680 ADVANCE(R) TOT COND FEMORAL PC KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. 048598094

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention