BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - EPOCA

    MDR report key: 2841243 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03302
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Product Code
    HSD
    PMA / PMN Number
    K072578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. NO PART OR LOT NUMBER OF DEVICE PROVIDED, THEREFORE NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. DEVICE NOT BEING RETURNED FOR EVALUATION, NO FURTHER EVALUATION CAN BE PERFORMED. DEVICE MANUFACTURE DATE NOT ABLE TO BE DETERMINED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH EPOCA SHOULDER PROSTHESIS ON UNKNOWN DATE FOR PROXIMAL HUMERUS FRACTURE. IT IS REPORTED PATIENT PRESENTED WITH INFECTION ON UNKNOWN DATE, APPROXIMATELY SIX (6) MONTHS POST OP. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. ANTIBIOTIC BEADS AND A METHYLMETHACRYLATE SPACER WERE PLACED INTO THE JOINT SPACE FOR FUTURE REVISION SURGERY. IT IS ANTICIPATED ANOTHER PROSTHESIS WILL BE IMPLANTED AFTER INFECTION HAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - EPOCA EPOCA HEAD HSD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention