BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3870487 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20898
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, A POPPING/SNAPPING SENSATION AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DIFFICULTY WALKING AND TROUBLE PERFORMING NORMAL DAILY ACTIVITIES. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC RIGHT FEMUR FRACTURE. OPERATIVE NOTES REPORTED OF FRACTURE HEMATOMA AND THE BALL WAS KNOCKED OFF THE PROXIMAL ASPECT OF THE FEMORAL PROSTHESIS AND THERE'S NO BONY INGROWTH INTO THE IMPLANT PROXIMALLY. IT WAS ALSO REPORTED OF CORONAL SPLIT IN THE GREATER PORTION OF THE FRACTURE IN ADDITION TO THE SUBCHONDRAL SPLIT. IT WAS REPORTED THAT THERE WAS DIFFICULTY IN RELEASING THE DISTAL ASPECT OF THE STEM. RADIOGRAPHS DEMONSTRATED A DISPLACED FRACTURE WITH WHAT APPEARED TO BE LOOSENING OF THE STEM PROXIMALLY. THERE IS NO LABORATORY RESULT FOR THE ALLEGED TOXIC METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348774 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910 1971673

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other