BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE ACETABULAR SYSTEM

    MDR report key: 2463049 · Received February 13, 2012

    Report

    Report Number
    1226188-2012-00005
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Report Date
    November 2, 2010
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    LPH
    PMA / PMN Number
    K031110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED ACETABULAR INSERT WAS EVALUATED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. THE ACETABULAR INSERT HAD NO OBVIOUS INCONSISTENCIES. THE PROBLEM COULD NOT BE REPRODUCED WITH THE RETURNED ACETABULAR INSERT.

    Description of Event or Problem · 1

    THE SURGEON EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO SEAT THE UHMWPE ACETABULAR INSERT INTO THE ACETABULAR SHELL. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE ACETABULAR SYSTEM HIP-JOINT, SEMI-CONSTRAINED, UNCEMENTED LPH OMNILIFE SCIENCE INC. 2414

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR