BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 2277440 · Received September 29, 2011

    Report

    Report Number
    3003640913-2011-00021
    Event Type
    Injury
    Date Received
    September 29, 2011
    Date of Event
    August 16, 2011
    Report Date
    September 29, 2011
    Manufacturer
    WALDEMAR LINK GMBH & COMPANY
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POLY BROKEN DUE TO SUBSIDENCE AND MALALIGNMENT.

    Description of Event or Problem · 1

    PT HAD STAR COMPONENTS REMOVED AND REPLACED WITH AN ARTHRODESIS NAIL DUE TO SUBSIDENCE 9 YEARS AFTER INITIAL IMPLANT. TALAR COMPONENT: (B)(4), LOT #110698/612. TIBIAL COMPONENT: (B)(4), LOT #000308/0226. POLY COMPONENT: (B)(4), LOT #8002447.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TOTAL ANKLE REPLACEMENT STAR TOTAL ANKLE NTG WALDEMAR LINK GMBH & COMPANY 400-256 110698/612

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention