BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISCOVERY ELBOW

    MDR report key: 3800715 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03742
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; PMA/510(K) NUMBER/ MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278805 UNKNOWN DISCOVERY ELBOW PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R