BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS PRESS FIT HUMERAL STEM

    MDR report key: 6148022 · Received December 6, 2016

    Report

    Report Number
    3000931034-2016-00205
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386915765
    PMA / PMN Number
    K980244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 11 YEARS POST-OPERATIVE DUE TO LOOSENING/LYSIS. THE IMPLANTED STEM, HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. CONVERSION INTO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800105 AEQUALIS PRESS FIT HUMERAL STEM SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S. DIA.11 L115 03700386915765

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other