BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2942027 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-02151
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 10, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN REOPENED BECAUSE PRODUCT INFORMATION HAS BEEN RECEIVED WHICH MAY CHANGE THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-10203. THIS REPORT, 1818910-2013-02151, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-10203.

    Additional Manufacturer Narrative · 1

    UPDATE: 1/10/2013 CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS AND HAD SUSTAINED A PERIPROSTHETIC FRACTURE AFTER THEY TRIPPED AND FELL. DOR: (B)(6) 2012. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE LINER PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL HEAD DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 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

    CLINICAL REPORT STATES THAT THE PATIENT HAS MIGRATION/LOOSENING OF STEM. UPDATE: (B)(4) 2013, CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS AND HAD SUSTAINED A PERIPROSTHETIC FRACTURE AFTER THEY TRIPPED AND FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47089 ARTICULEZE M HEAD 36MM +1.5 HEAD JDI DEPUY INTERNATIONAL 2519370

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention