BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML PLUS 50MM GR2

    MDR report key: 1931354 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-09801
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K861979
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    PATIENT WAS REVISED TO ADDRESS LINER AND CUP THAT HAD WORN THROUGH. OSTEOLYSIS AND LOOSENING OF THE CUP WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML PLUS 50MM GR2 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention