BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX-LNK POLY ACETABULAR CUP LINERS

    MDR report key: 1081661 · Received July 23, 2008

    Report

    Report Number
    1226188-2008-00019
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 22, 2008
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWB
    PMA / PMN Number
    K062489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RETURNED ACETABULAR INSERT (LOT# 2531) WAS MEASURED FOR CRITICAL DIMENSIONS. NO DIMENSIONAL ISSUES WERE FOUND. THE INSERT WAS ASSEMBLED USING A CUSTOM MADE IMPACTOR (USED TO SEAT THE LINER IN THE ACETABULAR SHELL) WHICH WAS SUPPLIED TO THE SURGEON UPON HIS REQUEST. WHEN COMPARED TO INSERTION WITH THE STANDARD IMPACTOR, THE CUSTOM IMPACTOR APPEARED TO BE MORE RESISTANT TO FULLY SEATING THE ACETABULAR INSERT.

    Description of Event or Problem · 1

    APEX-LNK INSERT DID NOT SEAT PROPERLY. SURGEON WAS ABLE TO SEAT ANOTHER INSERT FROM THE SAME LOT INTO THE ACETABULAR CUP. DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX-LNK POLY ACETABULAR CUP LINERS UHMWPE ACETABULAR INSERT KWB OMNI LIFE SCIENCE, INC. 2531

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R