BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4122394 · Received September 18, 2014

    Report

    Report Number
    3003640913-2014-00067
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING. MODEL#: 99-0028/11. LOT#: 1236065. EXPIRATION DATE: 10/01/2017. DEVICE MANUFACTURE DATE: 10/2012. TIBIAL COMPONENT. MODEL#: 400-262. LOT#: 100325/0130. EXPIRATION DATE: 07/01/2015. DEVICE MANUFACTURE DATE: 07/2010. COMPANY REPORT FORM STATES THERE WAS GOOD OSSEOINTEGRATION ON THE TIBIAL COMPONENT, BUT TALAR COMPONENT WAS LOOSE. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 99-0028/11, LOT NO. 1236065. THE DHR FOR PART NO. 400-252 NOTES THAT 1 OUT OF 40 PIECES WERE DISCARDED; AND FOR PART NO. 400-262, LOT NO. 100325/0130 NOTES THAT 4 OUT OF 40 PIECES WERE DISCARDED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED DUE TO PATIENT'S TALAR FRACTURE AND SUBSIDED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579277 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-252 091217/3297

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention