BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 58 OR 70ODX32ID

    MDR report key: 3203714 · Received July 3, 2013

    Report

    Report Number
    1818910-2013-20463
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 12, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    PK900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. PER THE INITIAL REPORTING BY THE DEPUY CLINICAL TEAM, NO ADDITIONAL INFORMATION IS AVAILABLE. ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. THE INVESTIGATION HAS DETERMINED THIS PRODUCT CODE IS OBSOLETE. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS 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.

    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

    CLINICAL REPORT STATES THE PATIENT HAD A LINER AND HEAD EXCHANGE WITH BONE GRAFTING FOR WEAR AND OSTEOLYSIS 18.5 YEARS AFTER PRIMARY THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306055 ENDURON 10D 58 OR 70ODX32ID LINER JDL 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention