BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD END PEG GLEN 44

    MDR report key: 1170001 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-04036
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWT
    PMA / PMN Number
    K905786
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. REVIEW OF THE AS400 FOUND TEN PIECES WERE RELEASED FOR DISTRIBUTION ON OCTOBER 02, 2003. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD END PEG GLEN 44 87KWT KWT DEPUY ORTHOPAEDICS, INC. NA X31BP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention