BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS ULNA 2.5X84 W/TAPER

    MDR report key: 3043489 · Received April 9, 2013

    Report

    Report Number
    0001825034-2013-00892
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00547-1 & 00892).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ELBOW ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A LOCKING SCREW FROM THE MEDIAL HUMERAL CONDYLE BEARING BACKING OUT. THE POLY WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147605 RS ULNA 2.5X84 W/TAPER PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 998080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R