BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ULNA 3X75MM RT W/BEARING

    MDR report key: 3000311 · Received March 12, 2013

    Report

    Report Number
    0001825034-2013-00568
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    August 18, 2010
    Report Date
    February 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK043505
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00568 & 00571).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ELBOW ARTHROPLASTY ON (B)(6) 2006 AND WAS REVISED ON (B)(6) 2010 DUE TO UNKNOWN REASONS. ANOTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO THE ULNAR COMPONENT PERFORATING THE PATIENT'S ULNAR CORTEX WHEN THE PATIENT FELL. THE ULNAR COMPONENT AND CONDYLE KIT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102665 DISCOVERY ULNA 3X75MM RT W/BEARING PROSTHESIS, ELBOW KWT BIOMET ORTHOPEDICS N/A 921080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R