BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISC HUM 4X150MM RT FLANGED C

    MDR report key: 3053024 · Received April 11, 2013

    Report

    Report Number
    0001825034-2013-00931
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 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
    MD, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00929 / 00931).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6)2013 DUE TO AN INFECTION. THE IMPLANTS WERE REMOVED AND CEMENT SPACERS WERE PLACED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156567 DISC HUM 4X150MM RT FLANGED C PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 254250

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R