BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) TOT COND FEMORAL NON-POROUS

    MDR report key: 4122578 · Received September 26, 2014

    Report

    Report Number
    3010536692-2014-01432
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-01433 AND 0144. THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE IMPLANT WAS CAUSING UNEXPLAINED PAIN. ALL TESTS CAME BACK NEGATIVE BUT THE PATIENT AGREED TO A REVISION SURGERY. AN ADVANCE CCK WAS IMPLANTED AT THE REVISION OF THIS TKR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601054 ADVANCE(R) TOT COND FEMORAL NON-POROUS KFTC-NP2R JWH MICROPORT ORTHOPEDICS INC. 027410571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention