BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 3040183 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15020
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    June 14, 2012
    Report Date
    March 22, 2013
    Manufacturer
    DEPUY IRELAND 9616671
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. AS THE CASE IS IN LITIGATION, FOLLOW UP FOR THIS ADDITIONAL INFORMATION WILL BE PERFORMED BY DEPUY LEGAL. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    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.

    Additional Manufacturer Narrative · 1

    REVISION DUE TO INCREASING METAL ION LEVELS AND SUBSEQUENT SOFT TISSUE AND MUSCLE PAIN. UPDATE OCT 18, 2017: ADDITIONAL INFORMATION RECEIVED. UPDATED PATIENT'S AFFECTED SIDE(RIGHT). ADDED REASON FOR REVISION: ALVAL AND PRODUCT MANUFACTURING DATE. THIS COMPLAINT WAS UPDATE ON NOV 17, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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.

    Description of Event or Problem · 1

    REVISION DUE TO INCREASING METAL ION LEVELS AND SUBSEQUENT SOFT TISSUE AND MUSCLE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144102 ARTICULEZE M HEAD 36MM -2 HIP FEMORAL HEAD JDI DEPUY IRELAND 9616671 2273836

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention