BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITI STANDARD HUMERAL HEAD 52X18MM

    MDR report key: 3133739 · Received May 23, 2013

    Report

    Report Number
    3004983210-2013-00005
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    November 2, 2012
    Report Date
    December 21, 2012
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    PMA / PMN Number
    K060988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    INFECTION. JOINT ASPIRATION PURULENT. I AND D OF RIGHT SHOULDER AND REPLACEMENT OF HUMERAL HEAD. ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228350 AFFINITI STANDARD HUMERAL HEAD 52X18MM NONE KWS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention