BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4364321 · Received December 22, 2014

    Report

    Report Number
    3003640913-2014-00097
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 1, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING MODEL#: 99-0028/12, LOT#: 1236067, EXPIRATIONS DATE: 10/01/2017, DEVICE MANUFACTURE DATE: 10/2012. STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT, MODEL#: 400-257, LOT#: 091204/2557, EXPIRATION DATE: 04/01/2015, DEVICE MANUFACTURE DATE: 04/2010. COMPANY REPORT FORM STATES PT'S ANKLE WAS IN VALGUS AND THE PT DID NOT HAVE DELTOID FUNCTION. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NO 99-0028/12, LOT NO. 1236067. THE DHR FOR PART NO 400-257, LOT NO. 091204/2557 NOTES THAT 3 OUT OF 40 PIECES WERE DISCARDED, AND 1 WAS SUBJECT TO REWORK. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED, AND THE PT'S ANKLE WAS REVISED TO FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843059 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-264 110602/2526

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention