BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE HUM HD 44X15

    MDR report key: 1842183 · Received September 20, 2010

    Report

    Report Number
    1818910-2010-06849
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWT
    PMA / PMN Number
    K984541
    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. REVIEW OF THE AS400 SYSTEMS SHOW THAT 6 OTHER DEVICES FROM BOTH OF THE REPORTED LOTS HAVE BEEN DELIVERED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE HUM HD 44X15 87KWT 87HSD KWT DEPUY ORTHOPAEDICS, INC. NA WJ3A51007

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention