BEUDAMED
    FDA Adverse Event Injury Summary report: N

    +4 ENDURON LINER 28ID X 48OD

    MDR report key: 1902180 · Received November 15, 2010

    Report

    Report Number
    1818910-2010-07894
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K902396
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFO. ALTHOUGH THE REPORT CANNOT BE CONFIRMED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFO 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 TO ADDRESS GROIN PAIN. POLY WEAR OF THE LINER AND LOOSENING OF THE CUP WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +4 ENDURON LINER 28ID X 48OD 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA 987350006

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention