BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 4193616 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30462
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 25, 2012
    Report Date
    October 10, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. NO REASON FOR REVISION HAS BEEN IDENTIFIED AND NO FURTHER INFORMATION OR INVESTIGATIONAL INPUTS HAVE BEEN MADE AVAILABLE. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE 1837698 LOT CODE. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINING PART/LOT COMBINATION. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6). REASON FOR REVISION NOT PROVIDED. ADDITIONAL INFORMATION REPORTS PATIENT ACTIVITY LEVEL IMPAIRED, NO RESTRICTED ROM, CAN WALK 5-15 MINUTES WITHOUT PAIN. UPDATE (B)(6) 2014 - COMPLAINT REOPENED AS FORMAL CLAIM RECEIVED FROM (B)(6). PATIENT COMPLAINING OF ACHING, DISCOMFORT AND PAIN. CLAIM CONFIRMS POSSIBLE RADIOLUCENCY NOTED IN (B)(6) 2012, ASSOCIATED WITH RIGHT ACETABULAR COMPONENT. CT SCAN (B)(6) 2012 SHOWED 2 CAVITIES IN RIGHT SIDE ACETABULAR. DURING REVISION TRUNNION WEAR NOTED WITH OXIDATION AND BLACKENING, BONE GRAFTING REQUIRED FOR CAVITIES. HISTOLOGY REPORT CONFIRMED ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671437 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 1837698

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention