BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE ACETABULAR SYSTEM

    MDR report key: 2463041 · Received February 14, 2012

    Report

    Report Number
    1226188-2012-00009
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    October 13, 2011
    Report Date
    October 14, 2011
    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 ACETABULAR INSERT COULD NOT BE EVALUATED, BECAUSE THE ACETABULAR INSERT WAS NOT RETURNED, SINCE THE ACETABULAR INSERT WAS LOST BY HOSPITAL SERVICES.

    Description of Event or Problem · 1

    THE SURGEON EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO SEAT THE UHMWPE ACETABULAR INSERT INTO THE ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE ACETABULAR SYSTEM HIP-JOINT, SEMI-CONSTRAINED, UNCEMENTED LPH OMNILIFE SCIENCE INC. 2349

    Patients

    Seq Age Sex Outcome Treatment
    1