BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 28ID

    MDR report key: 4623818 · Received March 23, 2015

    Report

    Report Number
    1818910-2015-16874
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES PROCEDURE: REVISION OF LEFT HIP DUE TO LYSIS AND PAIN. SURGEON HAS REMOVED AND REPLACED THE COMPONENTS. THE AML CLRMMA PROX PC 10.5 (CODE 135612000, LOT 822930) IS STILL IN SITU; THIS CODE IS NOT RECOGNIZED BY SYNERGY. PRIMARY PROCEDURE WAS ON (B)(6) 1995 BY DR (B)(6) AT (B)(6) HOSPITAL. IT SHOULD BE NOTED THE IMPLANTS WERE IN SITU FOR APPROX. 10 YEARS. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCTS THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER (B)(4). 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: REVISION OF LEFT HIP DUE TO LYSIS AND PAIN. SURGEON HAS REMOVE AND REPLACED THE COMPONENTS. THE AML CLRMMA PROX PC 10.5 (CODE 135612000, LOT 822930) IS STILL IN SITU, THIS CODE IS NOT RECOGNIZED BY SYNERGY. PRIMARY PROCEDURE WAS ON (B)(6). PHOTOGRAPH IS AVAILABLE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193446 ENDURON 10D 54OD X 28ID HIP ACETABULAR INSERT/LINER JWH DEPUY IRELAND 9616671 M3046

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention