BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3871185 · Received June 13, 2014

    Report

    Report Number
    1818910-2014-20951
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 6, 2013
    Report Date
    May 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.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

    ADDITIONAL NARRATIVE: 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 LOT CODES REQUIRED WERE NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A MEDICAL PROFESSIONAL. 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, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT WAS REVISED BECAUSE OF INCREASED ION LEVELS, PAIN, AND OSTEOLYSIS. UPDATE REC'D (B)(4) 2013 -LEGAL CLAIM RECEIVED. THE DOI WAS PROVIDED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, ELEVATED COBALT CHROMIUM LEVELS, AND A PSEUDOTUMOR. UPON REVISION, DEBRIS AND NECROTIC BONE AND TISSUE WERE REMOVED. POST OPERATIVE DIAGNOSIS, "ADVERSE LOCAL TISSUE REACTION DUE TO METAL ON METAL THA WITH COMPLETE ABDUCTOR DEFICIENCY." UPDATE REC'D (B)(4) 2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DIFFICULTY AMBULATING. IT WAS ALSO NOTED DURING REVISION SURGERY THAT "BROWN GELATINOUS TYPE DEBRIS" WAS REMOVED. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014. UPDATE REC'D (B)(4) 2014¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED THAT OBSERVED A BREAK IN THE GREATER TROCHANTER. THE BREAK DIDN¿T HAVE TO BE REPAIRED. THE DATE IS OF THIS BREAK IS UNKNOWN SO THE UNKNOWN STEM IS BEING REPORTED. THE REVISION OPERATIVE NOTE ALSO INDICATED THERE WAS A PROUD SCREW IN THE CUP THAT HAD TO BE SCREWED BACK IN. A UNKNOWN SCREW IS BEING REPORTED. THE REVISION OPERATIVE NOTE ALSO CONFIRMED A PSEUDOTUMOR. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351284 ARTICULEZE M HEAD 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2206071

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention