BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 14

    MDR report key: 2781945 · Received October 11, 2012

    Report

    Report Number
    1818910-2012-22718
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    August 15, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RECALL WAS PERFORMED IN 2004 CONCERNING CORAIL AMT STEMS. THE REFERENCES CONCERNED BY THIS RECALL WERE THE FOLLOWING : (B)(4). THE BATCHES CONCERNED BY THIS RECALL WERE : ALL BATCHES LESS THAN (B)(4). THIS RECALL WAS PERFORMED BECAUSE THE CONCERNING PARTS WERE LASER ETCHED ON THE NECK AND SUBSEQUENTLY THERE WERE A RISK OF FRACTURE OF THE STEM. THE REFERENCE / BATCH INVOLVED IN THE CURRENT COMPLAINT (B)(4) IS PART OF THE BATCHES CONCERNED BY THE RECALL. AS A CONSEQUENCE, THE ROOT CAUSE OF THE NECK FRACTURE IS THE ETCHING LOCATED ON THE NECK. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    CORAIL NECK FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 LAT COXA VARA SIZE 14 DEPUY HIP STEM KWA DEPUY FRANCE 1287048

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention