BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 3850058 · Received June 4, 2014

    Report

    Report Number
    1818910-2014-20230
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    January 6, 2012
    Report Date
    August 5, 2014
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. 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- LEFT. REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL- LEFT, REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: (B)(6) 2014 - MARKED AS LEGAL, ADDED (B)(6) REFERENCE NUMBER, ADDED HOSPITALS: (B)(6) HOSPITAL / (B)(6) HOSPITAL AND ADDED SURGEONS: DR (B)(6)/ DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326229 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS-3003895575 2425531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention