BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3121770 · Received May 10, 2013

    Report

    Report Number
    3003640913-2013-00022
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    HSN
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD STAR SLIDING CORE BEARING COMPONENT REVISED AFTER 3.5 YEARS OF IMPLANTATION. COMPANY REPORT FORM INDICATES POLY WAS FRACTURED. DEVICE HISTORY RECORD SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    PATIENT HAD STAR SLIDING CORE BEARING REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208397 STAR TOTAL ANKLE REPLACEMENT STAR SLIDING CORE COMPONENT HSN SMALL BONE INNOVATIONS, INC. 400-142 0912070

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CLEANED GUTTERS