BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX INTERFACE ACETABULAR SYSTEM

    MDR report key: 2260304 · Received September 1, 2011

    Report

    Report Number
    1226188-2011-00011
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K062489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INSERT WAS MEASURED FOR CRITICAL DIMENSIONS AND WAS FOUND TO BE IN MANUFACTURING SPECIFICATION. THE INSERT WAS THEN SEATED IN AN IN-HOUSE SHELL SAMPLE USING THE APICAL PLUG THAT WAS ALSO RETURNED WITH THE PRODUCT. THE INSERT FULLY SEATED IN THE SHELL AND LOCKED IN PLACE. NO DEFECTS WERE IDENTIFIED IN THE ASSEMBLY OF THE RETURNED DEVICE. THE MOST PROBABLE CAUSE FOR THIS EVENT IS DUE TO THE ACETABULAR SHELL NOT BEING CLEANED OUT PROPERLY BEFORE ATTEMPTING TO SEAT THE INSERT. THE PRODUCT PACKAGE INSTRUCTIONS STATE THAT THE DEVICE INTERFACES SHOULD BE CLEAN AND FREE FROM DEBRIS PRIOR TO ASSEMBLY. THE COMPLAINT ISSUE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    UHMWPE INSERT WOULD NOT SEAT INTO THE ACETABULAR SHELL. THIS CAUSED A DELAY IN SURGERY BY 15-20 MIN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER INSERT OF THE SAME SIZE. PATIENT IS DOING WELL POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX INTERFACE ACETABULAR SYSTEM ACETABULAR INSERT, 10DEG HOOD LPH OMNILIFE SCIENCE, INC. 5601

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR