BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC CONSTRAINED LINER II

    MDR report key: 1192883 · Received October 10, 2008

    Report

    Report Number
    1825034-2008-00264
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    KWZ
    PMA / PMN Number
    K021728
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    BRAND NAME AND CATALOG NUMBER CORRECTED. EVALUATION OF DEVICE SHOWED EVIDENCE OF RIM IMPINGEMENT FROM THE NECK OF THE FEMORAL STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE IN 2008. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURE SIX WEEKS LATER DUE TO LUXATION BETWEEN THE MODULAR HEAD AND LINER COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE IN 2008. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURE AT APPROXIMATELY 49 DAYS LATER, DUE TO LUXATION BETWEEN THE MODULAR HEAD AND LINER COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC CONSTRAINED LINER II PROSTHESIS, HIP COMPONENT KWZ BIOMET INC. N/A 629310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R