BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 3944845 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23781
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 26, 2014
    Report Date
    August 11, 2014
    Manufacturer
    DEPUY INTL., LTD.8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS REPORT IS STILL CONSIDERED CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE PROVIDED INSERT PRODUCT/LOT CODE COMBINATION. NO OTHER REPORTS FOUND AGAINST THE FEMORAL HEAD. PER PROCEDURE, THESE PRODUCT CODES ARE EXEMPT FROM DEVICE HISTORY RECORD REVIEW. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. 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

    PATIENT WAS REVISED TO ADDRESS PAIN AND METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE 9/14/15- PFS AND MEDICAL RECORDS WERE RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED METALLOSIS, DISLOCATION, TISSUE STAINING, HIGH LEVELS OF COBALT AND CHROMIUM. LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS DATED (B)(6) 2014 WITH SERUM COBALT 12.6MCG/L (REF 0.1-0.4MCG/L) AND SERUM CHROMIUM 10.7MCG/L (REF <1.5MCG/L). A PRE-OPERATIVE RADIOLOGY REPORT INDICATED POSSIBLE OSTEOLYSIS OR METALLOSIS. NO OSTEOLYSIS WAS INDICATED DURING THE REVISION OPERATIVE NOTE. PART / LOT UPDATED. THE COMPLAINT WAS UPDATED ON OCTOBER 9, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422613 ARTICULEZE M HEAD 36MM -2 HIP FEMORAL HEAD JDI DEPUY INTL., LTD.8010379 2510086

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention