BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22.2MM DIA COCR MODULAR HEAD -5 NK

    MDR report key: 3365034 · Received September 24, 2013

    Report

    Report Number
    0001825034-2013-04075
    Event Type
    Injury
    Date Received
    September 24, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. THE ACETABULAR CUP, MODULAR HEAD AND LINER WERE REMOVED AND REPLACED WITH A CONSTRAINED HIP SYSTEM. ONLY THE MODULAR HEAD WAS MANUFACTURED BY BIOMET ORTHOPEDICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482031 22.2MM DIA COCR MODULAR HEAD -5 NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 392230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R