BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BI-POLAR CUP

    MDR report key: 1051547 · Received May 16, 2008

    Report

    Report Number
    1825034-2008-00121
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    May 22, 2006
    Report Date
    June 26, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K051569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO 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. UPON RECEIPT OF THE DEVICE, DURING ATTEMPT TO DISASSEMBLE COMPONENTS, IMPLANT WAS DAMAGED TO THE POINT WERE NO FURTHER ANALYSIS COULD BE CONDUCTED. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED. THIS REPORT FILED ON 5/16/08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BI-POLAR PROCEDURE IN 2006, THE POLYETHYLENE LINER COULD NOT BE ASSEMBLED OR REMOVED FROM THE METAL SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC BI-POLAR CUP JDI BIOMET, INC. NA 806660

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK