BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3640743 · Received January 31, 2014

    Report

    Report Number
    3003640913-2014-00005
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT: MODEL #: 400-263, LOT #: 091119/(B)(4), EXPIRATION DATE: 02/01/2015, DATE OF IMPLANTATION: (B)(6) 2011, DATE OF EXPLANTATION: (B)(6) 2014; DEVICE MANUFACTURE DATE: 02/2010. STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT: MODEL #: 400-257, LOT #: 100422/(B)(4), EXPIRATION DATE: 07/01/2015, DATE OF IMPLANTATION: (B)(6) 2011, DATE OF EXPLANATION: (B)(6) 2014; DEVICE MANUFACTURE DATE: 07/2010. VISUAL EXAMINATION CONFIRMS WEAR ON TIBIAL COMPONENT, AND FRACTURE OF SLIDING CORE MOBILE BEARING. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 99-0028/12, LOT 0912075; THE DHR FOR PART NO. 400-257, LOT 100422/(B)(4) NOTED THAT (B)(4) PIECES WERE DISCARDED; THE DHR FOR PART NO. 400-263 LOT 091119/(B)(4) NOTED THAT (B)(4) PIECES WERE DISCARDED, AND 6 WERE REWORKED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SYSTEM WAS REMOVED DUE TO FRACTURED SLIDING CORE MOBILE BEARING AND MAL-ALIGNMENT. THE PT'S ANKLE WAS REVISED TO FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68263 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 99-0028/12 0912075

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention