BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEQUALIS GLENOID SPHERE 42MM

    MDR report key: 2385981 · Received December 19, 2011

    Report

    Report Number
    9610667-2011-00032
    Event Type
    Other
    Date Received
    December 19, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 22, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    PMA / PMN Number
    K030941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DUE TO PT INFECTION, GLENOSPHERE WAS REMOVED ALONG WITH POLY TO WASH OUT AND THEN REIMPLANT NEW PARTS WITH ANTIBIOTIC BEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEQUALIS GLENOID SPHERE 42MM GLENOID SPHERE KWS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention