BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRS - GLENOID RESURFACING SYSTEM

    MDR report key: 8681230 · Received June 8, 2019

    Report

    Report Number
    3004154314-2019-00004
    Event Type
    Malfunction
    Date Received
    June 8, 2019
    Report Date
    May 10, 2019
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWS
    PMA / PMN Number
    K091196
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. NO STERILITY, PACKAGING OR MANUFACTURING RELATED ISSUES WERE NOTED PER LOT DHR REVIEW. NO OTHER COMPLAINTS CONCERNING A SERIOUS INJURY OR A DEVICE MALFUNCTION WERE REPORTED FROM THIS DEVICE LOT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY. ARTHROSURFACE WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3004154314-2019-00002 AND 3004154314-2019-00003.

    Description of Event or Problem · 1

    ON 05/10/19, ARTHROSURFACE RECEIVED A VOLUNTARY FDA MEDWATCH REPORT FILED BY A PATIENT. PER THE REPORT, THE PATIENT RECEIVED ARTHROSURFACE GLENOID IMPLANT IN 2018. FOLLOWING THE INITIAL SURGERY, PATIENT UNDERWENT 3 ADDITIONAL SURGERIES LATER IN THE YEAR DUE TO ONGOING COMPLICATIONS WHICH INVOLVED PUS FORMATION AND LOOSENING OF THE GLENOID COMPONENT. THE PATIENT WAS CONCERNED SINCE THE ARTHROSURFACE DEVICE LOOSENED WITHIN LESS THAN 6 MONTHS OF IMPLANTATION. AT THE TIME OF THIS REPORT, THE PATIENT IS SCHEDULED FOR REVISION TO A REVERSE SHOULDER IMPLANT OF UNKNOWN MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474713 GRS - GLENOID RESURFACING SYSTEM SHOULDER JOINT PROSTHESIS, GLENOID COMPONENT KWS ARTHROSURFACE, INC. 75BG2343

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization