BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3131654 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17756
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 23, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE MDR DECISION.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH DID FIND ADDITIONAL RELATED REPORTS AGAINST THE METAL LINER AND/OR FEMORAL HEAD PRODUCT CODE AND LOT NUMBER COMBINATION(S). HOWEVER; A REVIEW OF THE DEVICE HISTORY RECORD(S) ASSOCIATED WITH THIS COMPLAINT WAS NOT REQUIRED PER (B)(4). A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE REMAINING PRODUCT CODE/LOT CODE COMBINATION(S). A CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED LOCAL TISSUE REACTION AND OSTEOLYSIS. THE CUP WAS THOUGHT TO BE LOOSE, BUT WAS NOTED TO BE STABLE. THE STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS-NO LABS PROVIDED. PART/LOT IS BEING UPDATED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233949 ARTICULEZE M HEAD 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 1218603

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other