BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 5517629 · Received March 22, 2016

    Report

    Report Number
    1818910-2016-15941
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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

    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

    FUNCTIONAL TESTING OF THE RETURNED DEVICE COULD NOT REPLICATE THE REPORTED PROBLEM. THE DEVICE LOCKED AND UNLOCKED AS DESIGN INTENDED. A COMPLAINT DATABASE SEARCH AGAINST PRODUCT CODE 865034 DID NOT REVEAL ANY TREND OF REPORTED LOCKING MECHANISM FAILURES. NO EVIDENCE WAS FOUND OF PRODUCT MALFUNCTION AND 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

    WHEN THE HANDLE IS IN THE LOCK POSITION, THE HANDLE DOES NOT LOCK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171790 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. NB58606

    Patients

    Seq Age Sex Outcome Treatment
    1