BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTED HUMERAL STEM 6.5

    MDR report key: 3863026 · Received June 6, 2014

    Report

    Report Number
    1038671-2014-00201
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    January 15, 2014
    Report Date
    June 5, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REVISION OF EQUINOXE SHOULDER COMPONENTS APPROX. 1 YEAR POST OP DUE TO ASEPTIC LOOSENING. TH IS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331468 CEMENTED HUMERAL STEM 6.5 CEMENTED HUMERAL STEM 6.5 KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R