BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2881665 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-29220
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    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

    UPDATE - (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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

    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

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2006, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP IMPLANT ON HIS RIGHT SIDE. THE IMPLANT CAUSED METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN HIS RIGHT THIGH AND GROIN. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY. **UPDATE** (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910 2138891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other