BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADPTR/I-BEAM PROS

    MDR report key: 389855 · Received April 25, 2002

    Report

    Report Number
    1818910-2002-00217
    Event Type
    Injury
    Date Received
    April 25, 2002
    Report Date
    April 25, 2002
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN SURGERY, AN I-BEAM CATHCART IMPLANT WAS USED; CATALOG NUMBER 1045-24-000; LOT NUMBER UN2E61004. THE SURGEON WANTED TO REMOVE THE IMPLANT DURING THE PROCEDURE TO REPOSITION IT. THE REMOVAL INSTRUMENT; CATALOG NUMBERS 2046-10-000 AND 2046-28-000 WOULD NOT FIT INTO THE THREADS ON THE IMPLANT. THE THREADED HOLE IN THE LATERAL SHOULDER OF THE STEM WAS TOO BIG TO ACCEPT THE END OF THE REMOVAL INSTRUMENT AND ADAPTER. THE SURGEON WAS ABLE TO EXTRACT THE IMPLANT IN ANOTHR MANNER; REPOSITION IT AND IMPLANT IT. A SECOND STEM, ALSO CATALOG NUMBER 1045-24-000, WAS OPENED. THE REMOVAL INSTRUMENT WOULD NOT FIT IT EITHER. THEY THEN TRIED IT IN ANOTHER IMPLANT; THIS TIME ANOTHER SIZE: 1045-16-00. IT FIT PERFECTLY IN THIS SIZE. FINALLY: THEY TRIED A THIRD SIZE; 1045-22-000. THIS THIRD SIZE HAD THE SAME PROBLEM AS THE ORIGINAL: THE HOLE WAS TOO BIG. SURGERY WAS EXTENDED 35 - 45 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADPTR/I-BEAM PROS MANUAL ORTHOPAEDIC DEVICE LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other