BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS POLY W/10 LIP 32 GR2

    MDR report key: 2012613 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02822
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K861979
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    PT REVISED TO ADDRESS OSTEOLYSIS AND POLYETHYLENE WEAR OF LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS POLY W/10 LIP 32 GR2 87 JDL JDL DEPUY ORTHOPAEDICS, INC. NA 522200

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention