BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEQUALIS RESURFACING HUMERAL HEAD 52X19MM

    MDR report key: 2542703 · Received April 9, 2012

    Report

    Report Number
    9610667-2012-00007
    Event Type
    Other
    Date Received
    April 9, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 16, 2012
    Manufacturer
    TORNIER, INC.
    Product Code
    HSD
    PMA / PMN Number
    K062661
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    PT PRESENTED WITH AN INFECTION ROUGHLY 9-MONTHS POST OPERATIVE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEQUALIS RESURFACING HUMERAL HEAD 52X19MM NONE HSD TORNIER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention