BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS KEELED SPHERICAL BASE GLENOID MEDIUM

    MDR report key: 3223820 · Received July 10, 2013

    Report

    Report Number
    9610667-2013-00161
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 17, 2013
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    PMA / PMN Number
    K994392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OPERATION OF THE LEFT SHOULDER, FOLLOWING THE DISCOVERY OF A LABRUM IMPLANT BROKE AND MOVED INTO THE JOINT. THE IMPLANTS WAS PLACED 2009-(B)(6) AT HOSPITAL (B)(6). SURGICAL RE-INTERVENTION AND RECOVERY OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316034 AEQUALIS KEELED SPHERICAL BASE GLENOID MEDIUM NONE KWS TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention