BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 2862730 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25570
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 9, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 12 ASR TOTAL HIP REPLACEMENT KWA DEPUY FRANCE 2437337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention