BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 8473501 · Received April 2, 2019

    Report

    Report Number
    1818910-2019-89329
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    August 17, 2011
    Report Date
    April 24, 2012
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    UDI-DI
    10603295168775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT 1860160 . THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR NON-CONFORMANCE. (B)(4). H10 ADDITIONAL NARRATIVE: ADDED: D4 (LOT), H6 PATIENT CODES. CORRECTED: H6 DEVICE CODES. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE SURGICAL INTERVENTION AND BLOOD HEAVY METAL INCREASED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005; DOR: (B)(6) 2011; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266730 CORAIL2 STD SIZE 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 3L92511 1860160 10603295168775

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention