BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3948929 · Received June 20, 2014

    Report

    Report Number
    3003640913-2014-00050
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 29, 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 #: 1018054. EXPIRATION DATE: 05/01/2017. DEVICE MANUFACTURE DATE: 05/2012. ADDITIONAL REMOVED COMPONENTS: TALAR COMPONENT. MODEL #: 400-255. LOT #: 100603/5368. EXPIRATION DATE: 03/01/2018. DEVICE MANUFACTURE DATE: 03/01/2013. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NO. 400-142, LOT NO. 1018054, PART NO. 400-263 LOT NO. 130304/0091 DISCARDED 1 PIECE AND REWORKED 1 PIECE OUT OF A TOTAL OF 20. THE DHR FOR PART NO. 400-258, LOT 100603/5368 NOTES THAT 3 PIECES WERE DISCARDED AND 7 PIECES WERE REWORKED OUT OF A TOTAL OF 40. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. VISUAL EXAMINATION CONFIRMS INSUFFICIENT OSSEOINTEGRATION ON THE TALAR COMPONENT. A FAIR AMOUNT OF BONE GROWTH WAS EVIDENT ON THE TIBIAL COMPONENT, BUT FIBROUS TISSUE WAS ALSO FOUND THERE. THE SLIDING CORE MOBILE BEARING SHOWS NO SIGNS OF EXCESSIVE WEAR.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED DUE TO ANKLE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363168 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 1300304/0091

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention