BEUDAMED
    FDA Adverse Event Injury Summary report: N

    +4 ENDURON LINER 28ID X 50OD

    MDR report key: 1842542 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06409
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE REPORT STATES: THE PATIENT WAS REVISED TO ADDRESS POLY-WEAR AFTER EIGHT YEARS. IT WAS REPORTED THAT THE PATIENT WAS SUBLUXING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +4 ENDURON LINER 28ID X 50OD 87HRY LPH DEPUY ORTHOPAEDICS, INC. NA V2XD7A007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention