BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3063644 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15502
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    January 31, 2012
    Report Date
    July 22, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE 2452400 . A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2275343 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, PSEUDOTUMOR, ELEVATED COBALT LEVELS, BONE LOSS AND OSTEOLYSIS.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, GREATER TROCHANTER, RIGHT HIP, STATUS POST TOTAL HIP ARTHROPLASTY SECONDARY TO THE DEVELOPMENT OF REACTIVE PSEUDOTUMOR. REVISION NOTES REPORTED THAT ABDUCTORS WERE SOMEWHAT ATROPHIED. THERE WAS BROWNISH FLUID DISCOLORATION IN THE PSEUDOTUMOR CONSISTENT WITH HEMOSIDERIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165143 ARTICULEZE M HEAD 36MM +1.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2452400

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention