BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 8

    MDR report key: 3951488 · Received July 22, 2014

    Report

    Report Number
    1818910-2014-24015
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 19, 2014
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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; RIGHT; REASON(S) FOR REVISION: COMPONENT LOOSENING (STEM) / PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428758 CORAIL2 STD SIZE 8 HIP FEMORAL STEM/SLEEVE KXA DEPUY FRANCE SAS-3003895575 2074612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention