BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3778334 · Received April 23, 2014

    Report

    Report Number
    3003640913-2014-00034
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-140, LOT #: 1037003, EXPIRATION DATE: 05/01/2017, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION:(B)(6) 2014, DEVICE MANUFACTURE DATE: 05/2012. STAR TOTAL ANKLE REPLACEMENT: TALAR COMPONENT, MODEL #: 400-255, LOT #: 100603/5337, EXPIRATION DATE: 02/01/2018, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 02/2013. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-140, LOT NO. 1037003, OR PART NO. 400-264, LOT 100305/0164; THE DHR FOR PART NO. 400-255, LOT NO. 100603/5337 NOTES THAT 3 OUT OF 40 PIECES WERE DISCARDED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. COMPANY REPORT FORM STATES PATIENT APPEARED TO HAVE A MEDIAL MALLEOLUS IMPINGEMENT. VISUAL EXAMINATION SHOWS MARKINGS CONSISTENT WITH THIS CONDITION. VISUAL EXAMINATION FURTHER CONFIRMS UNUSUAL MARKINGS ON ALL THREE COMPONENTS THAT SUGGESTS A 3RD BODY MATERIAL HAD COME IN CONTACT WITH THE COMPONENTS.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245841 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-264 100305/0164

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention