BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, ELBOW, HEMI-, RADIAL

    MDR report key: 8452714 · Received March 26, 2019

    Report

    Report Number
    3025141-2019-00173
    Event Type
    Injury
    Date Received
    March 26, 2019
    Report Date
    March 1, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    KWI
    PMA / PMN Number
    K131845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00174: CASE 2; 3025141-2019-00175: CASE 3; 3025141-2019-00176: CASE 4; 3025141-2019-00177: CASE 5; 3025141-2019-00178: CASE 6.

    Description of Event or Problem · 1

    ARTICLE: FAILURE OF METAL RADIAL HEAD REPLACEMENT. VAN RIET, R. P., SANCHEZ-SOTELO, J., MORREY, B. F., J BONE JOINT SURG (BR) 2010; 92-B:661-7. CASE 1: REVISION SURGERY PERFORMED FOR REASONS THAT CANNOT BE DETERMINED FROM THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243927 PROSTHESIS, ELBOW, HEMI-, RADIAL KWI ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention