BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY S-ROM 20X15MM F LG. SLEEVE

    MDR report key: 1772281 · Received July 22, 2010

    Report

    Report Number
    1818910-2010-04785
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A LOOSE COMPETITOR'S CUP. LOOSENING OF THE DEPUY STEM WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY S-ROM 20X15MM F LG. SLEEVE TOTAL HIP PROSTHESIS KWA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention