BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS FRACTURE IMPLANT UNKNOWN

    MDR report key: 2977947 · Received February 21, 2013

    Report

    Report Number
    9610667-2013-00060
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    PMA / PMN Number
    K082120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    KRISHNAN, S.G., J.R. REINECK, ET AL. (2011). SHOULDER ARTHROPLASTY FOR FRACTURE: DOES A FRACTURE-SPECIFIC STEM MAKE A DIFFERENCE? CLINICAL ORTHOPAEDICS AND RELATED RESEARCH 469 (12): 3317-3323. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    PT FAILED THEIR INITIAL HEMIARTHROPLASTY DUE TO LACK OF TUBEROSITY HEALING AND WAS REVISED TO REVERSE TOTAL SHOULDER ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76684 AEQUALIS FRACTURE IMPLANT UNKNOWN NONE KWS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention