BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRS GLENOID RESURFACING SYSTEM

    MDR report key: 5361389 · Received January 12, 2016

    Report

    Report Number
    3004154314-2015-00011
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Date of Event
    August 11, 2015
    Report Date
    December 7, 2015
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWS
    PMA / PMN Number
    K091196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE FOR LOOSENING OF GLENOID COMPONENT IN THE PATIENT IS UNKNOWN. ARTHROSURFACE WAS NOTIFIED THAT THE IMPLANT WAS REMOVED AND REVISED TO A TOTAL SHOULDER IMPLANT OF ANOTHER MANUFACTURER ON 08/11/2015. THERE ARE NOT ENOUGH DETAILS TO INVESTIGATE SINCE THE PATIENT WAS REVISED AND THE COMPONENTS WERE DISCARDED. FOLLOWING ARE THE DATES THAT BELONG TO GLENOID COMPONENTS REMOVED FROM THE PATIENT. PART # 8H02-5248-W LOT # 75AD0813 MFG DT: 01/20/2014 EXP. DT: 01/31/2021. PART # 8156-0032-W LOT # 75ED0517 MFG DT: 05/14/2014 EXP. DT: 05/31/2019. NOTE: THE EVENT WAS INITIALLY REPORTED TO ARTHROSURFACE AS A REVISION AND WAS NOT DOCUMENTED AS A CUSTOMER COMPLAINT. AFTER A RECENT REVIEW OF THE REVISION FORM BY A QUALITY PERSONNEL, THE CASE WAS PERCEIVED AS A CUSTOMER COMPLAINT AND REPORTABLE ON 12/07/2015. ALL THE SUPPORTING INFORMATION WILL BE DOCUMENTED IN THE COMPLAINT FILE AS A PART OF ARTHROSURFACE QUALITY SYSTEM.

    Description of Event or Problem · 1

    THE PATIENT'S GLENOID IMPLANT WAS REPORTED LOOSENED. THE INITIAL SURGERY DATE WAS (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19624 GRS GLENOID RESURFACING SYSTEM SHOULDER JOINT PROSTHESIS, GLENOID COMPONENT KWS ARTHROSURFACE, INC. 75AD0813/ 75ED0517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other