BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD HYL PEG GLENOID 48

    MDR report key: 2401861 · Received January 6, 2012

    Report

    Report Number
    1818910-2012-00561
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWS
    PMA / PMN Number
    K944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. 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 AND POSSIBLE INFECTION. OSTEOLYSIS WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD HYL PEG GLENOID 48 SHOULDER REPLACEMENT IMPLANT KWS DEPUY WARSAW 781890

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention