BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4122391 · Received September 18, 2014

    Report

    Report Number
    3003640913-2014-00069
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 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: TIBIAL COMPONENT, MODEL#: 400-263, LOT#: 100204/2634, EXPIRATION DATE: 03/01/2015. DEVICE MANUFACTURE DATE: 03/2010. TALAR COMPONENT, MODEL#: 400-257, LOT#: 091204/2541, EXPIRATION DATE: 04/01/2015, DEVICE MANUFACTURE DATE: 04/2010. VISUAL EXAMINATION CONFIRMS THAT THE DEGRADATION OF THE SLIDING CORE MOBILE BEARING IS CONSISTENT WITH AN UNSTABLE ANKLE. THE DHR FOR PART NO. 400-144, LOT NO. 0940060 SHOWS NO DEVIATIONS. THE DHR FOR PART NO. 400-263, LOT 100204/2634 NOTES THAT (B)(4) WERE SUBJECT TO REWORK; AND THE DHR FOR PART NO. 400-257, LOT NO. 091204/2541 NOTES THAT (B)(4) PIECES WERE SUBJECT TO REWORK, AND 3 PIECES WERE DISCARDED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SYSTEM WAS REMOVED AND REVISED TO FUSION. THE SLIDING CORE MOBILE BEARING IS DEGRADED FOLLOWING THE PATIENT'S FRACTURE OF THE MEDICAL MALLEOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579203 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-144 0940060

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention