BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4076378 · Received September 2, 2014

    Report

    Report Number
    3003640913-2014-00065
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 13, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING. MODEL#: 400-142, LOT#: 1314086, EXPIRATION DATE: 04/01/2018. DEVICE MANUFACTURER DATE: 04/01/2013. COMPANY REPORT FROM STATES NO IMPLANT FAILURE WITH INSIGNIFICANT WEAR TO SLIDING CORE MOBILE BEARING. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-142, LOT NO. 1314086. THE DHR FOR PART NO. 400-264, LOT NO. 130409/0303 NOTES THAT (B)(4). ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT AND SLIDING CORE MOBILE BEARING WERE EXCHANGED TO CORRECT A PERIPROSTHETIC FRACTURE IN THE PATIENT'S ANKLE AND AN IMPLANT SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532104 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-264 130409/0303

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention