BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE HUM HD 44X15

    MDR report key: 2082868 · Received May 3, 2011

    Report

    Report Number
    1818910-2011-07553
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWT
    PMA / PMN Number
    K984541
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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 MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECS OR CONTRIBUTING TO THE REPORTED EVENT. 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 REVISED FOR GREATER TUBEROSITY FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE HUM HD 44X15 87 KWT, HSD KWT DEPUY ORTHOPAEDICS, INC. NA EB9LE1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention