BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TESS GLENOID

    MDR report key: 6656591 · Received June 21, 2017

    Report

    Report Number
    3006946279-2017-00119
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY M. STAMILLA, J. TEISSIER, P. TEISSIER, S. AVONDO, AND G. SESSA. 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. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. STAMILLA, M. ET AL. " THE FUTURE OF SHOULDER IS STEMLESS: 107 CASES OF TOTAL SHOULDER ARTHROPLASTY WITH STEMLESS PROSTHESIS AFTER A MEAN 6.5-YEAR FOLLOW-UP". J ORTHOPAED TRAUMATOL (2014) 15 (SUPPL 1):S2. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FIVE (5) PATIENTS WERE REVISED DUE TO GLENOID COMPONENT FAILURE AFTER A SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437668 UNKNOWN TESS GLENOID PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R