BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOFOR

    MDR report key: 940940 · Received November 8, 2007

    Report

    Report Number
    9612771-2007-00050
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    October 31, 2003
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "RETROSPECTIVE ONE-TIME SUMMARY REPORT". THIS REPORT COVERS A TOTAL OF (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 IMPLANTED CUP AND METAL ABRASION ON THE BALL HEAD WAS REPORTED IN A CASE IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOFOR LZO PLUS ORTHOPEDICS AG 13906-C 0201.13.0404

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention BIOLOX FORTE CERAMIC BALL HEAD (LOT 01@6364| BOFOR PE-INSERT HOODED (LOT 0201.13.0259)| CENTERPULSE WAGNER STEM (ART# NA| CENTERPULSE WAGNER STEM (ART# NA| BIOLOX FORTE CERAMIC BALL HEAD (LOT 01@6364| BOFOR PE-INSERT HOODED (LOT 0201.13.0259)