BEUDAMED
    FDA Adverse Event Other Summary report: N

    I.T.I LSF ACETABULAR CUP LINER

    MDR report key: 223921 · Received May 18, 1999

    Report

    Report Number
    2245518-1999-00001
    Event Type
    Other
    Date Received
    May 18, 1999
    Date of Event
    October 5, 1993
    Report Date
    May 17, 1999
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY INC
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 6/7/1990, A TOTAL HIP REPLACEMENT SURGERY WAS PERFORMED ON A 30 YR OLD FEMALE PT. THE PRODUCT IMPLANTED WAS MFG BY IMPLANT TECHNOLOGY AND COMPONENTS WERE A 46MM OD ACETABULAR CUP WITH A 32MM ID POLYETHLENE LINER ALONG WITH A 32MM FEMORAL HEAD AND "LSF 2" FEMORAL STEM. ON 10/5/1993, THE PT UNDERWENT A REVISION SURGERY AND THE LINER WAS REPLACED AT THAT TIME WITH ANOTHER POLYETHYLENE LINER. BASED ON MEDICAL REPORTS RECENTLY PROVIDED TO OTI, IT WAS NOTED THAT THE ACETABULAR METAL SHELL WHICH WAS FIRMLY SEATED BUT SIGNIFICANTLY ANTEVERTED IN THE LEFT ACETABULUM WAS LEFT IN PLACE AND ONLY THE LINER WAS REPLACED AT THAT TIME. ON 11/7/1996, THE PT UNDERWENT A SECOND REVISION SURGERY. THE METAL SHELL AND LINER WERE REMOVED AND REPLACED AT THAT TIME. OTI ONLY RECENTLY BECAME AWARE OF THIS INFO AFTER BEING PROVIDED COPIES OF THE MEDICAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I.T.I LSF ACETABULAR CUP LINER Implant ORTHOPEDIC IMPLANT ACETABULAR CUP LINER KWB OSTEOIMPLANT TECHNOLOGY INC LSF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R