BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS POLY 20D 28 GR2

    MDR report key: 2012579 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-03003
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 WAS REVISED TO ADDRESS POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS POLY 20D 28 GR2 87HRY; 87HSX; 87JDB; 87JDI; 87JWH; 87KWT HRY DEPUY ORTHOPAEDICS, INC. NA UN9GMA002

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention