BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ANCHOR PEG GLENOID 48MM

    MDR report key: 3082383 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-16178
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK981487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. 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.

    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.

    Description of Event or Problem · 1

    PATIENT FELL AND FRACTURED GLENOID AFTER TOTAL SHOULDER REPLACEMENT, AND WAS TREATED NON-OPERATIVELY UNTIL ONSET OF PAIN FIVE YEARS LATER. DURING SURGERY TO ADDRESS THE PATIENT'S PAIN, OSTEOLYSIS, POLY WEAR, AND LOOSENING OF THE GLENOID AND STEM WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184621 GLOBAL ANCHOR PEG GLENOID 48MM GLENOID PROSTHESIS KWS 1818910 DEPUY ORTHOPAEDICS, INC. AP7EL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention