BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS IMPLANT UNK

    MDR report key: 2977979 · Received February 21, 2013

    Report

    Report Number
    9610667-2013-00008
    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

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. KHAN, A., T.D. BUNDER, ET AL. (2009). CLINICAL AND RADIOLOGICAL FOLLOW-UP OF THE AEQUALIS THIRD-GENERATION CEMENTED TOTAL SHOULDER REPLACEMENT: A MINIMUM TEN YEAR STUDY. JOURNAL OF BONE AND JOINT SURGERY SERIES B 91 (12): 1594-1600.

    Description of Event or Problem · 1

    REVISION FOR GLENOID LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76510 AEQUALIS IMPLANT UNK NONE KWS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention