BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 28ID

    MDR report key: 3192435 · Received June 27, 2013

    Report

    Report Number
    1818910-2013-19991
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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

    UPDATE: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE DOI WAS PROVIDED AS CALENDAR YEAR 1998. THIS PRODUCT/LOT COMBINATION WAS RELEASED IN JUNE 1999. THE EXACT DATE OF IMPLANT IS THEREFORE NOT KNOWN. IT IS REASONABLE HOWEVER TO CONCLUDE THE LINER WAS IMPLANTED FOR AN EXTENDED PERIOD OF TIME AND POLY MATERIAL WEAR NOT UNREASONABLE TO HAVE OCCURRED. BASED ON THE INVESTIGATION, 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

    PATIENT WAS REVISED TO ADDRESS SUPERIOR POLY WEAR AND A SENSATION THAT THE HIP WAS POPPING IN AND OUT. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294752 ENDURON 10D 54OD X 28ID ACETABULAR LINER HRY 1818910 DEPUY ORTHOPAEDICS, INC. TW1DA1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention