BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 3120431 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-05839
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    July 18, 2010
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    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

    ADDITIONAL NARRATIVE: 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: UNKNOWN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION; ASR XL - LEFT. REASON(S) FOR REVISION: UNKNOWN. (B)(4). BI-LATERAL PATIENT, PLEASE SEE (B)(4) FOR THE RIGHT SIDE REVISION. SURGEON CONFIRMATION FORM RECEIVED 2ND JULY 2014. HIP SIDE AMENDED. TAPER SLEEVE, ADDITIONAL HOSPITAL ADDED. IMPLANT AND REVISION DATES AMENDED. REVISION REASON ADDED. HIP(S) TO BE REVISED: RIGHT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. BI-LATERAL PATIENT, PLEASE SEE (B)(4) FOR THE RIGHT SIDE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221504 CORAIL2 STD SIZE 12 HIP FEMORAL STEM/SLEEVE MEH DEPUY INTERNATIONAL LTD. 8010379 3L92512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention