BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 13

    MDR report key: 3850020 · Received June 4, 2014

    Report

    Report Number
    1818910-2014-20209
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    October 9, 2013
    Report Date
    April 7, 2015
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL, RIGHT, REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION.ASR XL.RIGHT.REASON(S) FOR REVISION: PAIN.UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, ADDED SURGEONS X 2 , ADDED HOSPITAL, ADDED ALL EXPIRY DATES. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326159 CORAIL2 STD SIZE 13 HIP FEMORAL STEM/SLEEVE KXA DEPUY FRANCE SAS-3003895575 2387895

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention