BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO TOTAL WRIST CAPITATE STEM 6MM X 18MM

    MDR report key: 1644141 · Received March 29, 2010

    Report

    Report Number
    1825034-2010-00100
    Event Type
    Injury
    Date Received
    March 29, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    K080426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED DUE TO A SECOND PROCEDURE BEING PERFORMED AS A RESULT OF NOT HAVING THE PROPER IMPLANT AVAILABLE, DURING THE INITIAL PROCEDURE. THERE WAS NO PRODUCT NON-CONFORMANCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WRIST PROCEDURE ON (B) (6) 2010 THE IMPLANT NECESSARY FOR COMPLETION OF THE PROCEDURE WAS NOT CONTAINED WITHIN THE LOANER SET ORDERED. THE REQUIRED IMPLANT WAS ACTUALLY CONTAINED IN AN ALTERNATE LOANER SET. THE CORRECT SET WAS THEN IDENTIFIED AND ORDERED; THE PROCEDURE WAS COMPLETED EIGHT HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO TOTAL WRIST CAPITATE STEM 6MM X 18MM PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A 739010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R