BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 9

    MDR report key: 3964910 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24380
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    May 1, 2014
    Report Date
    October 28, 2014
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWY
    PMA / PMN Number
    PK123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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.

    Additional Manufacturer Narrative · 1

    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. 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, DIFFICULTY AMBULATING, LIMITED RANGE OF MOTION, LOOSENING OF THE FEMORAL COMPONENT, FRETTING AND CORROSION WHICH CAUSED METALS TO BE RELEASED INTO THE TISSUES SURROUNDING THE IMPLANTS, PSEUDOTUMOR, AND ELEVATED BLOOD SERUM LEVELS OF METAL IONS.

    Description of Event or Problem · 1

    UPDATE REC'D 10/28/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED LOOSE STEM, OSTEOLYSIS, INCREASED METAL IONS (NO LABS AT THIS TIME), AND PSUEDOTUMOR. THERE WAS NO MENTION OF CORRISON AS LITIGATION ALLEGED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441404 CORAIL2 NON COL HO SIZE 9 HIP FEMORAL STEM/SLEEVE KWY DEPUY FRANCE SAS - 3003895575 2251525

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R