BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BI-POLAR CUP

    MDR report key: 1052095 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00148
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    October 19, 2007
    Report Date
    November 14, 2007
    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

    EVALUATION OF RETURNED DEVICE FOUND POLYETHYLENE LINER DID NOT MEET DESIGN SPECIFICATIONS, THEREFORE, WOULD NOT SEAT IN METAL SHELL. 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 MAY 20, 2008.

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT IN RESPONSE TO FDA REQUEST FOR ADDITIONAL INFORMATION. INFORMATION HAS BEEN REQUESTED ON CORRECTIVE AND PREVENTIVE ACTION INITIATED FOR THE DEVICE REPORTED IN MEDWATCH REPORT 1825034-2008-00147. TO CLARIFY, BIOMET MEDWATCH REPORT INDICATED THAT CORRECTIVE AND PREVENTIVE ACTIONS WERE INITIATED IN RESPONSE TO A RECENT FDA AUDIT WHERE IT WAS SUGGESTED THAT BIOMET REASSESS POSSIBLE DEVICE MALFUNCTIONS THAT MAY MEET REPORTING REQUIREMENTS. THIS REPORT FILED JULY 22, 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HIP PROCEDURE IN 2007, THE SURGEON WAS UNABLE TO ASSEMBLE THE POLYETHYLENE LINER INTO THE METAL SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC BI-POLAR CUP PROSTHESIS, HIP COMPONENT JDI BIOMET, INC. NA 326400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK