BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20.0MM HEAD, LEFT

    MDR report key: 3842783 · Received January 15, 2014

    Report

    Report Number
    3025141-2014-00002
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 23, 2013
    Manufacturer
    ACUMED LLC
    Product Code
    KWI
    PMA / PMN Number
    K041858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR ASSOCIATED WITH THIS EVENT: 3025141-2014-00001, P/N TR-S0700-S, 7.0MM X 0.00MM STEM.

    Description of Event or Problem · 1

    DURING A RADIAL HEAD IMPLANTATION SURGERY, A 7MM HOLE WAS BROACHED WITH A 7MM BROACH; A 7MM TRIAL STEM FIT CORRECTLY. WHEN THE 7MM STERILE STEM (WITH 20.0MM HEAD, LEFT) IMPLANT WAS IMPLANTED, IT DID NOT FIT AND WOULD NOT STAY IN THE BROACHED HOLE. THE SURGEON THEN REFIT THE BROACHED HOLE WITH A 8MM STERILE STEM (WITH 22.0MM HEAD, LEFT) IMPLANT WHICH FIT SATISFACTORILY. THE MIS-FIT CAUSED AN EXTENSION IN SURGERY TIME FROM A PLANNED TIME OF 3 HOURS TO AN ACTUAL TIME OF 7 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39203 20.0MM HEAD, LEFT PROSTHESIS, ELBOW, HEMI-, RADIAL KWI ACUMED LLC TR-H200L-S 303515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention