BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4122390 · Received September 18, 2014

    Report

    Report Number
    3003640913-2014-00068
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING, MODEL#: 400-142, LOT#: 1314087, EXPIRATION DATE: 04/01/2018, DEVICE MANUFACTURE DATE: 04/2013. THE DHR FOR PART NO. 400-263, LOT NO. 130409/0478 NOTES THAT (B)(4) WERE DISCARDED; AND FOR PART NO. 400-142, LOT 1314087 NOTES THAT (B)(4) WERE ALSO DISCARDED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT WAS EXCHANGED AND THE SLIDING CORE MOBILE BEARING WAS UPSIZED TO ADDRESS THE PATIENT'S ANKLE IN 10 DEGREES VARUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578934 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 130409/0478

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention