BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRE CAPITELLAR COMP XLG/UK

    MDR report key: 5596842 · Received April 21, 2016

    Report

    Report Number
    3002806535-2016-00190
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 23, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDC
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT LATERAL PARTIAL ELBOW ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO FRACTURED AND LOOSE POLYETHYLENE, PAIN, AND SYNOVITIS. ALL COMPONENTS WERE REMOVED AND REPLACED WITH TOTAL ELBOW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249230 LRE CAPITELLAR COMP XLG/UK PROSTHESIS, ELBOW JDC BIOMET UK LTD. N/A 1936375

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R