BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISC HUM 4X100MM RT FLANGED C

    MDR report key: 4251175 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08622
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK013042
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿LOOSENING, MIGRATION, AND/OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ELBOW ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A LOOSE HUMERAL COMPONENT CAUSED BY PATIENT NONCOMPLIANCE AND FALL. THE HUMERAL COMPONENT, ULNAR COMPONENT AND CONDYLE KIT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737427 DISC HUM 4X100MM RT FLANGED C PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 950310

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R