BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT NECK SEG 125D KLA

    MDR report key: 7955671 · Received October 11, 2018

    Report

    Report Number
    1818910-2018-72102
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    October 3, 2018
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LZO
    UDI-DI
    10603295325154
    PMA / PMN Number
    K142004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT WAS DEEMED AS JUSTIFIED. 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. 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

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT WAS DEEMED AS JUSTIFIED 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RUBBER RING AND AREA BEHIND THE RUBBER RING IN EACH TRIAL NECK CONTAINS DRIED BLOOD WHEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796491 CORAIL AMT NECK SEG 125D KLA HIP INSTRUMENTS : FEMORAL TRIALS LZO DEPUY FRANCE SAS 3003895575 NB15315 10603295325154

    Patients

    Seq Age Sex Outcome Treatment
    1