BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - HUMERAL TRAY/BASEPLATE

    MDR report key: 3002786 · Received March 13, 2013

    Report

    Report Number
    0001825034-2013-00596
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO THE HUMERAL TRAY POSITIONED TOO FAR SUPERIORLY ON THE GLENOID. AS A RESULT THE HUMERAL TRAY WAS IMPINGING ON THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105269 UNKNOWN - HUMERAL TRAY/BASEPLATE PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R