BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 2863541 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25569
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 26, 2012
    Report Date
    January 22, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    MEH
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    ASR REVISION ASR XL - LEFT REASON(S) FOR REVISION: PAIN AND LOOSENING OF THE LEFT STEM.

    Description of Event or Problem · 1

    THE PATIENT HAD A REVISION ON THE RIGHT HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 12 HIP STEM MEH DEPUY FRANCE 2492156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention