BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRIGUE13X145MM POLISHED STEM

    MDR report key: 3638960 · Received February 21, 2014

    Report

    Report Number
    0001825034-2014-01030
    Event Type
    Injury
    Date Received
    February 21, 2014
    Date of Event
    December 11, 2003
    Report Date
    May 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDG
    PMA / PMN Number
    PK931194
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECT REVISION DATE.

    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 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 5 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01026 / 01030 AND 01032).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2003 DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON OCTOBER 14, 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2003 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110271 INTRIGUE13X145MM POLISHED STEM PROSTHESIS, HIP JDG BIOMET ORTHOPEDICS N/A 405000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R