BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMALLY INVASIVE SOLUTIONS TECHNOLOGY OFFSET RASP HANDLE

    MDR report key: 643582 · Received October 28, 2005

    Report

    Report Number
    1822565-2005-00207
    Event Type
    Injury
    Date Received
    October 28, 2005
    Date of Event
    September 15, 2005
    Report Date
    September 21, 2005
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    1822565-2/2/06-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED ON SEPTEMBER 15 2005, THE PT HAD AN ANTEROLATERAL HIP PROCEDURE. WHILE RASPING THE FEMUR, THE LOCKING CLIP DISENGAGED AND FELL INTO THE PT. THE DOCTOR NOTICED THE CLIP IN THE POST-OP X-RAYS. ON SEPTEMBER 15, 2005, THE CLIP WAS REMOVED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2005, THE PT HAD AN ANTEROLATERAL HIP PROCEDURE. WHILE RESPING THE FEMUR, THE LOCKING CLIP DISSENGAGED AND FELL INTO THE PT. THE DOCTOR NOTICED THE CLIP WAS REMOVED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT IS REPORTED IN SEPTEMBER 2005, THE PATIENT HAD AN ANTEROLATERAL HIP PROCEDURE. WHILE RASPING THE FEMUR, THE LOCKING CLIP DISENGAGED AND FELL INTO THE PATIENT. THE DOCTOR NOTICED THE CLIP IN THE POST-OP X-RAYS. IN SEPTEMBER 2005, THE CLIP WAS REMOVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMALLY INVASIVE SOLUTIONS TECHNOLOGY OFFSET RASP HANDLE HIP INSTRUMENT LXH ZIMMER, INC. NA 60278638

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R