BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS FRACTURE STEM

    MDR report key: 4864923 · Received June 22, 2015

    Report

    Report Number
    9610667-2015-00114
    Event Type
    Injury
    Date Received
    June 22, 2015
    Report Date
    May 28, 2015
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOILEAU P, WINTER M ET AL. (2013). CAN SURGEONS PREDICT WHAT MAKES A GOOD HEMIARTHROPLASTY FOR FRACTURE? J SHOULDER ELBOW SURG, 22:1495-1506. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    ONE REVISION PERFORMED FOR POSTOPERATIVE STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403070 AEQUALIS FRACTURE STEM NONE KWS TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention