BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD DS HYL KEEL GLEN 44

    MDR report key: 1220398 · Received November 3, 2008

    Report

    Report Number
    1818910-2008-05142
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFORMATION STATES INTRAOPERATIVELY IT WAS DISCOVERED THE HEAD TAPER WAS NOT ENGAGED, IT COULD SPIN FREELY ON THE STEM. PROVIDED INFORMATION ALSO STATES LYSIS WAS SUSPECTED IN THE PROXIMAL HUMERUS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY AND 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 ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING AND POLY WEAR OF THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD DS HYL KEEL GLEN 44 87KWT KWT DEPUY ORTHOPAEDICS, INC. NA 843470

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention