BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 52OD X 28ID

    MDR report key: 2071687 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06638
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING NEW INFORMATION FROM CLINICAL STUDY. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES FAILED ELITE PLUS STEM AND DURALOC LINER 10 YEARS AFTER IMPLANTATION. THIS IS A PATIENT RELATED EVENT. FURTHER INFORMATION FROM THE REP: THE ENDURON LINER FAILED DUE TO WEAR. THIS WEAR CAUSED MASSIVE OSTEOLYSIS AND A BIG HOLE IN PROXIMAL FEMUR WHICH IN TURN CAUSED INCREASED LOAD ON THE STEM AND THE STEM FRACTURED. A REVIEW OF MANUFACTURING RECORDS AND COMPLAINTS DATABASES DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED. 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

    THE DEVISE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A 5 YEAR SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO POLY WEAR, WHICH CAUSED MASSIVE OSTEOLYSIS AND A BIG HOLE IN PROXIMAL FEMUR WHICH IN TURN CAUSED INCREASED LOAD ON THE STEM AND THE STEM FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 52OD X 28ID 87HRY; 87HSX; 87JDB; 87JDI; 87JWH; 87KWA; 87KWT HRY DEPUY ORTHOPAEDICS, INC. NA VK5FB1068

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention