BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS RESURFACING HEAD

    MDR report key: 4864925 · Received June 22, 2015

    Report

    Report Number
    9610667-2015-00122
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    August 12, 2014
    Report Date
    June 4, 2015
    Manufacturer
    TORNIER SAS
    Product Code
    HSD
    PMA / PMN Number
    K131231
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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

    POST-OP COMPLICATION - LEFT SHOULDER. GLENOID EROSION/ARTHROSIS, ROTATOR CUFF RE-TEAR, P. ACNES INFECTION. PATIENT REVISED TO RSA ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403803 AEQUALIS RESURFACING HEAD NONE HSD TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention