BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 +3MM

    MDR report key: 1870314 · Received October 11, 2010

    Report

    Report Number
    1818910-2010-07178
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH REPORTED PART AND LOT NUMBER COMBINATIONS. A DEPUY (B)(4) SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECS AND FOUND NO MFG DEVIATIONS OR ANOMALIES. PROVIDED INFO STATES THE PT IS A CHRONIC DISLOCATE. (B)(4). 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 ADD'L 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 REVISED TO ADDRESS CHRONIC DISLOCATION.

    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 5033631

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention