BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT NECK SEG 135D KHO

    MDR report key: 11118548 · Received January 5, 2021

    Report

    Report Number
    1818910-2021-00295
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 17, 2020
    Report Date
    December 17, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295325178
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    SMALL METAL RING NOTICED TO BE MISSING ON KHO NECK TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12248 CORAIL AMT NECK SEG 135D KHO HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY FRANCE SAS - 3003895575 L94006 10603295325178

    Patients

    Seq Age Sex Outcome Treatment
    1