BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 4871960 · Received June 26, 2015

    Report

    Report Number
    1818910-2015-24513
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    April 30, 2014
    Report Date
    July 2, 2015
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE (B)(6) 2015-(B)(6) AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORD FOR MDR REPORTABILITY, DISCHARGE NOTES INDICATED THE PATIENT WAS REVISED ON (B)(6) 2014 FOR A LOOSE HIP AND PAIN. NO REVISION OPERATIVE NOTE WAS PROVIDED TO INDICATE WHICH IMPLANTS WERE LOOSE. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. THE STEM IS NOW BEING ADDED TO THE COMPLAINT. PART/LOT IS BEING UPDATED. THE COMPLAINT WAS UPDATED ON:(B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415080 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 2391652

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention