BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY HUMERAL STEM 4X200MM RT FLANGED C

    MDR report key: 3062969 · Received April 17, 2013

    Report

    Report Number
    0001825034-2013-01015
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK013042
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "LOOSENING, MIGRATION, AND/OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01012 / 01016).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL ELBOW ARTHROPLASTY ON (B)(6) 2011 AND THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2011 TO REMOVE AND REPLACE THE CONDYLE KIT AND HUMERAL STEM FOR UNKNOWN REASONS. A SUBSEQUENT REVISION PROCEDURE TOOK PLACE ON (B)(6) 2013 TO REMOVE AND REPLACE ALL COMPONENTS DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166033 DISCOVERY HUMERAL STEM 4X200MM RT FLANGED C PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 128410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R