BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 9897963 · Received March 30, 2020

    Report

    Report Number
    1818910-2020-09590
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    August 21, 2019
    Report Date
    July 1, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    UDI-DI
    10603295168782
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 : LOT 5013562. THE DHR ANALYSIS SHOWED AN INITIAL CONFORMANCE OF THIS PRODUCT / LOT WITH REGARDS TO ITS SPECIFICATION. THERE WAS NO DEVIATION OR NON-CONFORMANCE. DEVICE HISTORY REVIEW : LOT 5013562. THE DHR ANALYSIS SHOWED AN INITIAL CONFORMANCE OF THIS PRODUCT / LOT WITH REGARDS TO ITS SPECIFICATION. THERE WAS NO DEVIATION OR NON-CONFORMANCE.

    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: 5013562. THE DHR ANALYSIS SHOWED AN INITIAL CONFORMANCE OF THIS PRODUCT / LOT WITH REGARDS TO ITS SPECIFICATION. THERE WAS NO DEVIATION OR NON-CONFORMANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    MEDICAL RECORDS REPORT ALVAL, HYPERSENSITIVITY, PSEUDOTUMOR, PAIN, TENDINOSIS, BURSITIS, ELEVATED METAL ION LEVELS, METALLOSIS AND FLUID COLLECTION. THE PATIENT WAS THEN REVISED TO ADDRESS PAIN, PSEUDOTUMOR AND METAL ON METAL REACTION. A SIGNIFICANT AMOUNT OF SYNOVIAL FLUID WAS ENCOUNTERED WITHIN THE JOINT ALONG WITH MILD OR MINIMAL AMOUNTS OF TRUNNIONS AND METALLOSIS TYPE MATERIAL OR TISSUE. DOI: (B)(6) 2010. DOR: (B)(6) 2019, (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364679 CORAIL2 STD SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 3L92512 5013562 10603295168782

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CUP 121722052/EB9DH1000| HEAD 136551100/2991399| HOLE ELIMINATOR 124603000/EB5NS1| LINER 121887352/2987069| SCREW 121725500/418170| STEM 3L92512/5013562