BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BI-POLAR CUP

    MDR report key: 1030348 · Received April 15, 2008

    Report

    Report Number
    1825034-2008-00105
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 12, 2007
    Report Date
    April 19, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K051569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO RECENT FDA AUDIT, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. THIS REPORT FILED ON APRIL 15, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL BI-POLAR ARTHROPLASTY IN 2007. SURGEON WAS UNABLE TO ASSEMBLE LINER COMPONENT IN SHELL COMPONENT. ALTERNATE PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC BI-POLAR CUP JDI BIOMET, INC. NA 619510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other