BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND MBLOC HUM EPI 1 D10 STD

    MDR report key: 2093664 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08416
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. PROVIDED INFO STATES THE STEM HAD FRACTURED OUT THE LATERAL SIDE OF THE PT, REVISED TO A LONG STEM. 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 REVISED FOR LOOSE HUMERAL STEM CAUSED BY FRACTURE OUT OF LATERAL SIDE. REVISED TO A LONGER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND MBLOC HUM EPI 1 D10 STD 87 HSD, KWS HSD DEPUY FRANCE S.A.S.-SAINT PRIEST NA 5069797

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention