BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS-FIT ACETABULAR CUP

    MDR report key: 940942 · Received November 8, 2007

    Report

    Report Number
    9612771-2007-00051
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    October 26, 2005
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    "RETROSPECTIVE ONE-TIME SUMMARY REPORT" THIS REPORT COVERS A TOTAL OF ONE (1) SERIOUS INJURY MDR. THE REASON THE FOREIGN-SOURCE MDR REPORTABLE EVENTS (BEING SUBMITTED UNDER EXEMPTION) ARE BEING FILED LATE IS DUE TO A MISUNDERSTANDING BY THE MANUFACTURER, PLUS ORTHOPEDICS AG, OF THE MDR REQUIREMENTS APPLICABLE TO FOREIGN MANUFACTURERS. AT THE TIME OF THESE EVENTS PLUS ORTHOPEDICS AG ERRONEOUSLY BELIEVED THAT FOREIGN EVENTS WERE REPORTABLE ONLY IF THE EVENT INVOLVED A DEVICE FROM THE "SAME LOT" AS DEVICES THAT WERE DISTRIBUTED IN THE UNITED STATES. THUS THE MDR'S THAT ARE THE SUBJECT OF THIS RETROSPECTIVE ONE-TIME SUMMARY REPORT WERE NOT APPROPRIATELY EVALUATED FOR MDR REPORTABILITY, AND NOT REPORTED TO FDA. APPROPRIATE CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    LOOSENING OF THE TITANIUM SHELL WAS REPORTED IN A CASE IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS-FIT ACETABULAR CUP LZO PLUS ORTHOPEDICS AG 13625-A 9905.13.1579

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CERAMIC BALL HEAD (LOT 99@1142)| PLUS-FIT PE INSERT (LOT 9701.02.1996)| CERAMIC BALL HEAD (LOT 99@1142)| PLUS-FIT PE INSERT (LOT 9701.02.1996)