BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4170508 · Received October 9, 2014

    Report

    Report Number
    3003640913-2014-00073
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING, MODEL # 400-142, LOT # 1317095, EXPIRATION DATE: 08/01/2018, DEVICE MANUFACTURE DATE: 08/2013; TALAR COMPONENT, MODEL # 400-255, LOT # 130417/0220, EXPIRATION DATE: 07/01/2018, DEVICE MANUFACTURE DATE: 07/2013. VISUAL EXAMINATION CONFIRMS THE MARKS ON ALL THREE COMPONENTS ARE CONSISTENT WITH REMOVAL OF IMPLANT. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART # 400-142, LOT # 1317095. THE DHR FOR PART # 400-255, LOT NO. 130417/0220 DISCARDED 4 PIECES OUT OF A TOTAL OF 40. THE DHR FOR PART # 400-264, LOT 1408070 NOTES THAT 6 PIECES WERE DISCARDED OUT OF A TOTAL OF 40. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED AND ANKLE WAS FUSED DUE TO ANKLE PAIN. PAIN WAS MOST LIKELY A RESULT OF A REACQUIRING CONGENITAL DEFORMITY CAUSING LACK OF A PLANTIGRADE FOOT, AND UNSTABLE ANKLE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636919 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-264 1408070

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention