BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3591465 · Received January 9, 2014

    Report

    Report Number
    3003640913-2014-00001
    Event Type
    Injury
    Date Received
    January 9, 2014
    Date of Event
    December 10, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD A RE-OPERATION TO ADDRESS LATERAL PAIN. COMPANY REPORT FORM INDICATES THAT THE SURGEON REPLACED THE TIBIAL COMPONENT ADJUSTING THE LOCATION OF PLACEMENT, AND EXCHANGED THE SLIDING CORE MOBILE BEARING. THE DHR FOR PART NO. 400-141, LOT 1010032 SHOWS NO ANOMALIES; THE DHR FOR PART NO. 400-263, LOT 110602/2566 NOTED THAT (B)(4) PIECES WERE DISCARDED, AND (B)(4) WERE RE-WORKED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT HAD STAR TIBIAL COMPONENT AND SLIDING CORE MOBILE BEARING REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17771 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 110602/2566

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR STAR TOTAL ANKLE REPLACEMENT| EXPLANT:| MODEL#: 400-141, LOT#: 1010032, MFR DATE 12/2011| IMPLANT:| SLIDING CORE MOBILE BEARING