BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 12

    MDR report key: 2970217 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-03975
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    September 11, 2012
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN REOPENED BECAUSE PRODUCT INFORMATION HAS BEEN RECEIVED WHICH MAY CHANGE THE INVESTIGATION FOR THE STEM.

    Additional Manufacturer Narrative · 1

    A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE NEWLY PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. MEDICAL RECORDS AND X-RAYS WERE PROVIDED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS METAL-ON-METAL DISEASE, OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73901 CORAIL2 LAT COXA VARA SIZE 12 STEM KWA DEPUY FRANCE 2588673

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention