BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER NEUT 58 OR 70ODX28ID

    MDR report key: 1772348 · Received July 23, 2010

    Report

    Report Number
    1818910-2010-04803
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 REVISED FOR PAIN, FOUND ACETABULAR CYSTS AND POLYETHYLENE WEAR OF LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER NEUT 58 OR 70ODX28ID KWY, LZN, HRY, KWI, JDB KWY DEPUY ORTHOPAEDICS, INC. NA 514700

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention