BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 +6MM

    MDR report key: 1962313 · Received January 7, 2011

    Report

    Report Number
    1818910-2011-00101
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    DEPUY FRANCE S.A.S - ST PRIEST
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOR PAIN, POLYETHYLENE WEAR OF CUP, AND LOOSE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38 +6MM 87 HSD, KWS HSD DEPUY FRANCE S.A.S - ST PRIEST NA 2402479

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention