BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 2642212 · Received June 28, 2012

    Report

    Report Number
    3003640913-2012-00017
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    June 18, 2012
    Report Date
    June 28, 2012
    Manufacturer
    WALDEMAR LINK GMBH & COMPANY
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON REMOVED STAR COMPONENTS. POLY MOBILE BEARING INTACT. IMPLANTS SOLIDLY FIXED AND ALIGNED. REVIEW OF DEVICE HISTORY RECORDS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    PT HAD STAR COMPONENTS REMOVED. #400-255, LOT #00210/3201, EXP 06/2006, MFG 06/2001; #400-141, LOT #0916100, EXP 06/2014, MFG 06/2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TOTAL ANKLE REPLACEMENT TOTAL ANKLE REPLACEMENT NTG WALDEMAR LINK GMBH & COMPANY 400-263 20606/1208

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention LATERAL GUTTERS| REMOVED OSTEOPHYTES FROM MEDIAL AND