BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUERRERO LT TRFLNG 58MMXSZ25

    MDR report key: 3063494 · Received April 17, 2013

    Report

    Report Number
    0001825034-2013-01019
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    July 5, 2013
    Report Date
    November 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REVISION PROCEDURE DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 FIVE STATES, "IMPLANTS CAN LOOSEN OR MIGRATE DUE TO TRAUMA OR LOSS OF FIXATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP PROCEDURE UTILIZING A CUSTOM TRI-FLANGE ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS PULLING ON A PACKAGE STRAP, AND THEN STOOD UP AND TWISTED HIS BODY. THE CUSTOM TRI-FLANGE IMPLANT LOOSENED. A REVISION PROCEDURE HAS NOT BEEN SCHEDULED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A LOOSE TRI-FLANGE COMPONENT. THE TRI-FLANGE COMPONENT, MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165734 GUERRERO LT TRFLNG 58MMXSZ25 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 501830

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R