BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 + 3MM

    MDR report key: 1914086 · Received December 1, 2010

    Report

    Report Number
    1818910-2010-09238
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PROVIDED INFO STATES A 42MM ECCENTRIC GLENSOPHERE WAS USED WITH A 38 +3 POLY. THE PT WAS TAKEN BACK TO THE OPERATING ROOM, REMOVED THE 38 POLY AND REPLACED IT WITH A 42MM POLY; SURGEON CHOSE THE INCORRECT SIZE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A 42MM ECCENTRIC GLENOSPHERE AND A 38MM +3 PE CUP. THE PT WAS BROUGHT BACK TO THE OPERATING ROOM THE SAME DAY, AND THE 38MM PE CUP WAS REMOVED AND REPLACED WITH A 42MM PE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38 + 3MM 87KWS; 87HSD KWS DEPUY FRANCE S.A. NA 5036582

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention