BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEPUY

    MDR report key: 348947 · Received August 23, 2001

    Report

    Report Number
    348947
    Event Type
    Other
    Date Received
    August 23, 2001
    Date of Event
    July 24, 2001
    Report Date
    August 14, 2001
    Manufacturer
    DEPUY QUALITY ASSURANCE DEPT.
    Product Code
    JDK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LEFT TOTAL HIP PROCEDURE, THE SURGEON TAPPED THE DEVICE (RESTRICTOR) IN PLACE AND NOTICED THAT THE DEVICE WAS TOO SMALL. THE SURGEON TRIED TO REMOVE THE DEVICE. WHEN HE ATTEMPTED TO DO THIS THE DEVICE BROKE AS WELL AS PART OF THE STRAIGHT ROD. BOTH PLACES REMAIN INSIDE OF THE PT. THE SURGEON FELT IT WOULD BE TOO RISKY TO REMOVE THE RETAINED DEVICES. ANY ADVERSE AFFECT TO THE PT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38664 DEPUY BIOSTOP JDK DEPUY QUALITY ASSURANCE DEPT. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other