BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 14X22MM IMPLANT HEAD

    MDR report key: 3033756 · Received April 3, 2013

    Report

    Report Number
    0001825034-2013-00829
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    July 25, 2012
    Report Date
    March 8, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PK051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00828 / 00829).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF IMPLANTS FALLING APART. A REVIEW OF INVOICE HISTORY CONFIRMED THAT A STEM AND HEAD WERE IMPLANTED DURING THE REVISION. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON ON (B)(6) 2012. PATIENT ALLEGES THAT THE CURRENT SURGEON STATED THE ELBOW DEVICES REMOVED WERE TOO LARGE AND HAD WORN AWAY SOME OF HER BONE. PATIENT FURTHER ALLEGES THAT ALL COMPONENTS WERE REMOVED AND NO OTHER DEVICES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136612 EXPLOR 14X22MM IMPLANT HEAD PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A 792030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R