BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 58 OR 70ODX28ID

    MDR report key: 2251438 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18184
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    DURING A REVISION TO ADDRESS A PERIPROSTHETIC FRACTURE WHICH, IT IS REASONABLE TO CONCLUDE, WOULD NOT HAVE BEEN RELATED TO THE PRODUCT, POLY WAR WAS ALSO FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 58 OR 70ODX28ID ACETABULAR LINER LPH DEPUY RAYNHAM 523660021

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention