BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 56 OR 68ODX28ID

    MDR report key: 3253579 · Received July 30, 2013

    Report

    Report Number
    1818910-2013-22421
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    HRY
    PMA / PMN Number
    PK944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITHOUT DEVICE EXAMINATION. ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355353 ENDURON 10D 56 OR 68ODX28ID ACETABULAR LINER HRY 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 979700

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention