BEUDAMED
    FDA Adverse Event Injury Summary report: N

    00240000900

    MDR report key: 46326 · Received October 30, 1996

    Report

    Report Number
    1822565-1996-00634
    Event Type
    Injury
    Date Received
    October 30, 1996
    Date of Event
    November 30, 1995
    Report Date
    October 29, 1996
    Manufacturer
    ZIMMER, INC.
    Product Code
    KTW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #00-1131-002-32 LAG SCREW LOT #59638400. CATALOG #00-0318-002-00 PARHAM BANDS LOT #75553500. COMPRESSION SCREW & 9 BONE SCREWS, PART # & LOT #UNK EVALUATION CODES FOR SECTION H6:100-68, 100- THE DEVICE WAS EXAMINED IN THE RESEARCH LABORATORY, SEM INDICATES FATIGUE STRIATIONS AND THE EDS IS CONSISTANT WITH 316LSST AS REQUIRED. 68- FATIGUE STRIATIONS WERE OBSERVED ON THE FRACTURE SURFACE INDICATING THIS FRACTURE OCCURRED DUE TO METAL FATIGUE. SECTION F WAS COMPLETED BY THE MFR. INFO WAS REC'D THROUGH A CONSUMER. THE USER FACILITY HAS BEEN CONTACTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PT EXPERIENCED PAIN. X-RAYS REVEALED DEVICE HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 00240000900 Implant TUBE&PLT 135DX5.5PLTX9H KTW ZIMMER, INC. 4200 47916900

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention