BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD END FIN GLEN 52

    MDR report key: 2060671 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05924
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWT
    PMA / PMN Number
    K905786
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFORMATION STATES THE PATIENT HAD A FALL WHICH FRACTURED HIS GLENOID (BONE) WHICH LEAD TO THE LOOSENING. IT IS UNKNOWN THE CAUSE OF THE POLY WEAR. 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 BECAUSE HE HAD A FALL IN WHICH HE FRACTURED HIS GLENOID BONE, WHICH LED TO LOOSENING OF HIS GLENOID COMPONENT. POLY WEAR OF THE GLENOID COMPONENT WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD END FIN GLEN 52 87KWT KWT DEPUY ORTHOPAEDICS, INC. NA Y15BF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention