BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE M 36MM +1.5

    MDR report key: 3021265 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14456
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    July 26, 2012
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING FURTHER INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION. IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    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

    CONCLUSION AND JUSTIFICATION STATUS: A REVIEW OF THE MANUFACTURING RECORDS AND THE COMPLAINTS DATABASE DID NOT HIGHLIGHT ANY ANOMALIES OR ANY PREVIOUS TRENDS FOR THIS ISSUE. NO PRODUCT OR FURTHER INFORMATION WAS RECEIVED AND SO NO FURTHER INVESTIGATION COULD BE CARRIED OUT. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PATIENT WAS REVISED TO ADDRESS RAISED METAL IONS IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124048 ARTICUL/EZE M 36MM +1.5 HEAD BALL JDI DEPUY INTERNATIONAL LTD. 8010379 2664067

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention