BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY CONDYLE KIT TI W ALIGNMENT

    MDR report key: 4813338 · Received June 2, 2015

    Report

    Report Number
    0001825034-2015-02373
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    June 8, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK051975
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE IN DETERMINING ROOT CAUSE OF EVENT.

    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "LOOSENING OF IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE IMPLANTED - (B)(6) 2011. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY IN (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO METALLOSIS AND LOOSENING OF THE SCREWS IN THE CONDYLE. THE CONDYLES WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354493 DISCOVERY CONDYLE KIT TI W ALIGNMENT PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 986840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R