BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2871879 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-83321
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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. PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND PAIN. DOI (B)(6) 2012 - DOR (B)(6) 2012 (RIGHT HIP). UPDATE 12/28/2012: PATIENT'S MEDICAL RECORDS WERE RECEIVED. NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. C. OPERATIVE NOTES AND X-RAYS WERE OBTAINED. THE RADIOGRAPHS REVEAL WELL-POSITIONED, STABLE APPEARING COMPONENTS. WITH THE INFORMATION PROVIDED OSTEOLYSIS COULD NOT BE CONFIRMED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +8.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention