BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 48OD X 28ID

    MDR report key: 1162760 · Received September 15, 2008

    Report

    Report Number
    1818910-2008-04101
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODES REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. ALTHOUGH UNAVAILABLE FOR EVAL, IT WOULD NOT BE UNREASONABLE TO EXPECT SOME DEGREE OF POLY MATERIAL WEAR AFTER APPROX TEN YEARS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L 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 DISLOCATION. POLY WEAR WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 48OD X 28ID 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention