BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 9605054 · Received January 20, 2020

    Report

    Report Number
    1818910-2020-02234
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    November 5, 2019
    Report Date
    January 6, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    UDI-DI
    10603295168775
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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: 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 : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. 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 · 0

    ADDITIONAL INFORMATION RECEIVED FOR MEDICAL RECORDS. LAB VALUES FROM (B)(6) 2018: COBALT 7.1 MCG/L AND CHROMIUM 1.6 MCG/L. ON 05 NOV 2019, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP TO ADDRESS METALLOSIS, PAIN, AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE THE SURGEON NOTED INFLAMMATION, EXTENSIVE TRUNNIONOSIS WITH CORROSION ON THE MORSE TAPER ASPECT OF THE FEMORAL HEAD AND TRUNNION. THE ACETABULAR CUP AND FEMORAL STEM WERE NOTED TO BE WELL FIXED AND NOT REVISED.

    Additional Manufacturer Narrative · 1

    (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

    SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS ADVERSE LOCAL TISSUE REACTION. DATE OF IMPLANTATION: (B)(6) 2007, DATE OF REVISION: (B)(6) 2019, (LEFT HIP). LAB: HIGH COBALT BLOOD LEVEL 7.4 ((B)(6) 2018). METAL HEAD AND LINER REVISED. DEPUY COMPONENTS: CATALOG ID: 121701050, LOT: W75FV1012, DESCRIPTION: PINNACLE SHELL 100 SERIES 50MM. CATALOG ID: 121887350, LOT: 2367675, DESCRIPTION: ULTAMET LINER METAL 50MM X 36MM. CATALOG ID: 124603000, LOT: A82DD1000, DESCRIPTION: APEX HOLE ELIM POSITIVE STOP. CATALOG ID: 136552000, LOT: 2316631, DESCRIPTION: ARTICUL/EZE HEAD METAL 36MM +5. CATALOG ID: 3L92511, LOT: 1860160, DESCRIPTION: CORAIL STEM COLLARLESS SZ 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70452 CORAIL2 STD SIZE 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 3L92511 10603295168775

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention APEX HOLE ELIM POSITIVE STOP (124603000/A82DD1000)| PINNACLE 100 ACET CUP 50MM (121701050/W75FV1012)