BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REV FEM/TIB/SLEEVE CLAMP

    MDR report key: 6142644 · Received December 2, 2016

    Report

    Report Number
    1818910-2016-32760
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AGAINST THE PROVIDED PRODUCT CODE FOUND PREVIOUS SIMILAR REPORTED EVENTS. PREVIOUS INVESTIGATIONS ATTRIBUTED THE ROOT CAUSE TO EXCESSIVE TORQUE APPLIED TO THE HANDLE WHILE TIGHTENING STEMS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE CURRENT REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE INSTRUMENT NO LONGER HOLDS THE IMPLANT VERY WELL.

    Description of Event or Problem · 1

    THE INSTRUMENT NO LONGER HOLDS THE IMPLANT VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792678 REV FEM/TIB/SLEEVE CLAMP KNEE INSTRUMENT/TRIAL HXD DEPUY ORTHOPAEDICS, INC. H0210

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR