BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4218709 · Received October 30, 2014

    Report

    Report Number
    3003640913-2014-00082
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 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: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL#: 400-142; LOT#: 1250135; EXPIRATION DATE: 01/01/2018, DEVICE MANUFACTURE DATE: 01/2013. STAR TOTAL ANKLE REPLACEMENT, TALAR COMPONENT, MODEL#: 400-251, LOT#: 090316/0984; EXPIRATION DATE: 11/01/2014; DEVICE MANUFACTURER DATE: 11/2009. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NO. 400-142, LOT NO.1250135; AND PART NO. 400-251, LOT NO. 090316/0984. THE DHR FOR PART NO. 400-262, LOT NO. 100422/0286 NOTES THAT 4 OUT OF 40 PIECES WERE DISCARDED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    START TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED DUE TO IMPLANT LOOSENING MOST LIKELY CAUSED BY INADEQUATE OSSEOINTEGRATION. THE LACK OF OSSEOINTEGRATION IS BELIEVED TO BE ATTRIBUTED TO PATIENT'S FRACTURE TO THEIR MEDIAL MALLEOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696278 STAR TOTAL ANKLE REPLACEMENT NTG SMALL BONE INNOVATIONS, INC. 400-262 100422/0286

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention