BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TESS GLENOID COMPONENT

    MDR report key: 6692974 · Received July 7, 2017

    Report

    Report Number
    3006946279-2017-00126
    Event Type
    Injury
    Date Received
    July 7, 2017
    Report Date
    July 7, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060694. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AND NO PRODUCT WAS RETURNED. DHR AND COMPLAINT HISTORY COULD NOT BE REVIEWED DUE TO THE LACK OF INFORMATION RECEIVED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO SHOULDER ARTHROPLASTY REVISION DUE TO DETERIORATION OF THE GLENOID. A CUSTOM VRS (VAULT RECONSTRUCTION SYSTEM) HAS BEEN REQUESTED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474797 UNKNOWN TESS GLENOID COMPONENT PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention