BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT NECK SEG 125D KLA

    MDR report key: 8054683 · Received November 9, 2018

    Report

    Report Number
    1818910-2018-75045
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    June 25, 2018
    Report Date
    November 7, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295325154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICES WERE REVIEWED AND THE FAILURE MODE WAS CONFIRMED. 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. DEVICE HISTORY LOT: NB109568. 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

    SHORT NECK TRIAL OPTION IS MISSING THE METAL RING AT THE BASE OF THE TRUNNION WHICH SECURES THE HEAD TRIAL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894376 CORAIL AMT NECK SEG 125D KLA HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY FRANCE SAS - 3003895575 NB109568 10603295325154

    Patients

    Seq Age Sex Outcome Treatment
    1