BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3810445 · Received May 14, 2014

    Report

    Report Number
    1818910-2014-18787
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    March 7, 2012
    Report Date
    June 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.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

    (B)(4). ADDED: (PART/LOT/EXP DATE), (PATIENT).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT :(B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE JUL 5, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES VERY HIGH CHROMIUM AND COBALT LEVELS IN THE BLOOD, MASSIVE INFECTION (MRSA AND GROUP B STREP), AND RENAL FAILURE DUE TO ANTIBIOTIC THERAPY. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. LABORATORY VALUES FOR COBALT AND CHROMIUM WERE ABOVE 7PPB. PATHOLOGY REPORT STATED CHRONIC INFLAMMATION, FIBROSIS, AND FOREIGN BODY REACTION. CLINIC NOTES REPORT PSEUDOCYST, HIGH LEVELS OF COBALT. PART/LOT INFORMATION UPDATED. THIS COMPLAINT WAS UPDATED ON: JUL 26, 2017.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND HIGH LEVELS OF COBALT AND CHROMIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288955 ARTICULEZE M HEAD 36MM +5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 3073301

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention