BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS IMPLANT UNKNOWN

    MDR report key: 2977953 · Received February 21, 2013

    Report

    Report Number
    9610667-2013-00019
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    PMA / PMN Number
    K994392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    YOUNG, A.A., WALCH, G., ET AL. (2012). SECONDARY ROTATOR CUFF DYSFUNCTION FOLLOWING TOTAL SHOULDER ARTHROPLASTY FOR PRIMARY GLENOHUMERAL OSTEOARTHRITIS: RESULTS OF A MULTICENTER STUDY WITH MORE THAN FIVE YRS OF F/U. JOURNAL OF BONE AND JOINT SURGERY SERIES A 94 (8). JOURNAL ARTICLE PAGES 685-693. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    ONE REVISION PERFORMED FOR GLENOID COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76685 AEQUALIS IMPLANT UNKNOWN NONE KWS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention