BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    MDR report key: 7807534 · Received August 22, 2018

    Report

    Report Number
    1020279-2018-01591
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 31, 2018
    Report Date
    November 1, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, NO CLINICALLY RELEVANT DOCUMENTS WERE PROVIDED TO CONDUCT A THOROUGH MEDICAL ASSESSMENT. HOWEVER, IT WAS REPORTED THIS RESULTED IN NO HARM TO THE PATIENT. THEREFORE, NO FURTHER CLINICAL/MEDICAL INVESTIGATION IS WARRANTED AT THIS TIME. WE RECOMMEND THAT ALL RE-USABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR/DAMAGE AND REPLACED AS NECESSARY. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEGION REVISION CUTTING BLOCK DISASSEMBLED AND CAME APART IN PATIENT. 25 MIN DELAY. XRAYS WERE NEEDED TO MAKE SURE THAT NO PIECES WERE LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645985 INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention