BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 3821974 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04464
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN. THE HUMERAL HEAD WAS REMOVED AND A SMALLER HUMERAL HEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300228 UNKNOWN HUMERAL HEAD PROSTHESIS. SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R