BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR VAR NECK SEGMENT COR AMT

    MDR report key: 7471896 · Received April 30, 2018

    Report

    Report Number
    1818910-2018-58461
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 4, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295258223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. 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 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

    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 ALSO REPORTED THAT THE CORAIL KLA NECK TRIAL EXPANDABLE BUSHING HAS STRETCHED MAKING IT DIFFICULT TO TRIAL. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316228 COR VAR NECK SEGMENT COR AMT HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY FRANCE SAS - 3003895575 5284328 10603295258223

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR