BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETION FEM IMPAC/EXTRACTOR

    MDR report key: 6820919 · Received August 25, 2017

    Report

    Report Number
    1818910-2017-23480
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    UDI-DI
    10603295095422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED THE FEMORAL IMPACTOR AND THE SCREW BROKE ON THE FEMORAL INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602606 COMPLETION FEM IMPAC/EXTRACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN 10603295095422

    Patients

    Seq Age Sex Outcome Treatment
    1