BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3431078 · Received October 22, 2013

    Report

    Report Number
    3003640913-2013-00042
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    September 30, 2013
    Report Date
    September 30, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L REVISED COMPONENT: STAR TOTAL ANKLE REPLACEMENT, TIBIAL COMPONENT, MODEL #: 400-263, LOT #: 120399/128, DEVICE MANUFACTURE DATE: 06/01/1999, EXPIRATION DATE: 06/01/2004; STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE, MODEL #: 400-142, LOT #: A/26229, DEVICE MANUFACTURE DATE: 02/26/1999, EXPIRATION DATE: 02/01/2004. ALL THREE START COMPONENTS WERE REMOVED AFTER 14 YRS. PT'S ANKLE WAS FUSED. VISUAL EVAL SHOWS INCONSEQUENTIAL WEAR TO COMPONENTS. REVIEW OF MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    PT HAD THE STAR TOTAL ANKLE COMPONENTS REMOVED AND ANKLE COMPONENTS REMOVED AND ANKLE WAS FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540795 STAR TOTAL ANKLE REPLACEMENT STAR TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-259 070597/500

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention OSTEOPHYTE EXCISION| TARSAL TUNNEL RELEASE| ILIAC CREST BONE GRAFT| PERONEAL TENDON EXCISION| FEMORAL HEAD ALLOGRAFT