BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5X53MM DISC XS ULNA W/BC LT

    MDR report key: 3221745 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02544
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 28, 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

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. 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 EVENT (REFERENCE 1825034-2013-02544 AND 02634).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013, DUE TO LOOSENING OF THE ULNA BEARING. IT WAS NOTED DURING PROCEDURE THERE WAS ULNAR WEAR AND METALLOSIS WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320639 2.5X53MM DISC XS ULNA W/BC LT PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 625550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R