BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE4 RHEAD LATERAL STEM AND RADIAL HEAD

    MDR report key: 2212491 · Received April 4, 2008

    Report

    Report Number
    2212491
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 3, 2008
    Manufacturer
    SMALL BONE INNOVATIONS
    Product Code
    JDB
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED ELBOW JOINT. TWO PARTS TO THE DEVICE. LOT# AND REF # FOR BOTH PARTS ARE PROVIDED. DEVICE WAS SURGICALLY IMPLANTED AT (B)(6) HOSPITAL AND REMOVED/REPLACED AT AN OUTPATIENT ORTHOPEDIC SURGERY CENTER NOT ASSOCIATED WITH (B)(6) HOSPITAL. SURGEON SENT DEVICE TO FLAGLER HOSPITAL FOR PATHOLOGY REPORT. PHYSICIAN WAS CONTACTED AND REPORTED THAT THIS WAS A DEVICE FAILURE. MFR PLANS TO PICK UP DEVICE ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE4 RHEAD LATERAL STEM AND RADIAL HEAD TOTAL ELBOW PROSTHESIS JDB SMALL BONE INNOVATIONS 38551002
    2 SIZE4 RHEAD LATERAL STEM AND RADIAL HEAD TOTAL ELBOW PROSTHESIS JDB SMALL BONE INNOVATIONS 38555002

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention