BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 2982490 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12916
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PRODUCT AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE METAL HEAD AND LINER. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS RECEIVED FROM LEGAL. PFS ALLEGES THAT THE PATIENT SUFFERS FROM ELEVATED LEVELS OF COBALT CHROMIUM. ADDITIONALLY, IT IS ALLEGED THAT THE LEFT HIP SUFFERS FROM PAIN, POOR RANGE OF MOTION, AND DIFFICULTY AMBULATING. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM DISCOMFORT, SORENESS, DIFFICULTY WITH DAILY LIVING ACTIVITIES, AND TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD, TISSUE, AND BONE. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS RECEIVED FROM LEGAL. PFS ALLEGES THAT THE PATIENT SUFFERS FROM ELEVATED LEVELS OF COBALT CHROMIUM. ADDITIONALLY, IT IS ALLEGED THAT THE LEFT HIP SUFFERS FROM PAIN, POOR RANGE OF MOTION, AND DIFFICULTY AMBULATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87713 ARTICULEZE M HEAD 36MM -2 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2195271

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other