BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD HYL PEG GLENOID 52

    MDR report key: 1012320 · Received February 11, 2008

    Report

    Report Number
    1818910-2008-00919
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. PROVIDED INFO STATED THE SURGEON FELT THE LOOSENING AND WEAR OF THE GLENOID MAY HAVE BEEN CAUSED BY TOO MUCH PATIENT ACTIVITY, THE INSERT WAS IMPLANTED FOR TEN YEARS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR 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 TO ADDRESS LOOSE GLENOID, OSTEOLYSIS AND POLYETHYLENE WEAR NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD HYL PEG GLENOID 52 87KWY KWY DEPUY ORTHOPAEDICS, INC. NA SC4F91

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention