BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY CONDYLE KIT W/ HEXALOBULAR

    MDR report key: 3062965 · Received April 17, 2013

    Report

    Report Number
    0001825034-2013-01012
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    November 2, 2011
    Report Date
    March 20, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK051975
    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. THIS REPORT IS NUMBER 1 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
    164996 DISCOVERY CONDYLE KIT W/ HEXALOBULAR PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 942730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R