BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2978750 · Received February 26, 2013

    Report

    Report Number
    1818910-2013-04071
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    July 25, 2011
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART/LOT INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE..

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 2016626 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 1860634, 2140625, A2FE2100, 2186444 OR 2177967. PROVIDED MEDICAL RECORDS HAVE BEEN REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2006, PATIENT WAS IMPLANTED WITH RIGHT AND LEFT PINNACLE MOM HIPS RESPECTIVELY. HE LATER EXPERIENCED PAIN, WEAKNESS, AND DIFFICULTY WITH SIMPLE DAILY ACTIVITIES. PATIENTS DOCTOR PERFORMED A BONE SCAN, WHICH HAS SHOWN LOOSENING OF THE IMPLANT AND HAS SUGGESTED PATIENT MAY NEED A REVISION SURGERY. UPDATE: (B)(4) 2013 - CLINICAL REPORT STATES THE PATIENT WAS REVISED BECAUSE OF INFECTION, PAIN, STIFFNESS FOR THE LEFT HIP ONLY. DOR: (B)(6) 2013 (LEFT HIP), PART/LOT INFORMATION RECEIVED FOR THE LEFT HIP. INVOICE SEARCH FOUND THE PART/LOT INFORMATION FOR THE RIGHT HIP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82415 ARTICULEZE M HEAD 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2186444

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention