BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+8.5

    MDR report key: 2880373 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-28208
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED BY LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE ON DISC IF NEEDED FOR ADDITIONAL 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2010, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP ON HER LEFT SIDE. PATIENT HAS EXPERIENCED SWELLING, INFLAMMATION, GROIN PAIN, HIP PAIN, COMPLICATIONS WITH THE OPPOSITE HIP, SWELLING IN THE LEFT ANKLE, AND PROBLEMS SITTING, STANDING, AND MOVING UP AND DOWN STAIRS. PATIENT NOW FACES THE POTENTIAL FOR A REVISION SURGERY IN THE FUTURE. **UPDATE** (B)(6) 2012 - MEDICAL RECORDS WERE RECEIVED BY LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE ON DISC IF NEEDED FOR ADDITIONAL REVIEW.

    Description of Event or Problem · 1

    THERE WERE NO NEW ALLEGATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910 3064973

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention