BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D42 + 3MM

    MDR report key: 1233615 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-05079
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    PMA / PMN Number
    K081620
    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 WAS REVISED TO ADDRESS PAIN AND CHRONIC DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D42 + 3MM 87KWS & 87HSD KWS DEPUY FRANCE S.A. NA 2690185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention