BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 STD SIZE 14

    MDR report key: 8513947 · Received April 15, 2019

    Report

    Report Number
    1818910-2019-90637
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    May 26, 2015
    Report Date
    March 25, 2019
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    UDI-DI
    10603295168805
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. OCCUPATION: IS A NON-HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 1

    PATIENT SUBMITTED A MAUDE REPORT (MW-5040467) REPORTING ELEVATED METAL ION LEVELS AND THAT THE FEMORAL NECK IN INFLAMED. THEY ALSO STATED THEY NEED TO UNDERGO A REVISION SURGERY TO REPLACE THE METAL HEAD AND LINING. LITIGATION ALLEGES METAL WEAR AND LOOSENING OF STEM. DOI: (B)(6) 2008 - DOR: NONE, REPORTED (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307303 CORAIL2 STD SIZE 14 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS 3003895575 2501139 10603295168805

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other