BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID

    MDR report key: 3800823 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03713
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 10, 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
    NY, 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. PRODUCT IDENTIFICATION/EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - 2004, EXACT DATE IS UNKNOWN; PMA/510(K) NUMBER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY IN 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO A LOOSENED GLENOID. THE GLENOID AND HUMERAL HEAD WERE REPORTED TO HAVE BEEN REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279431 UNKNOWN GLENOID PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R