BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TESS HUMERAL INSERT

    MDR report key: 6606272 · Received June 1, 2017

    Report

    Report Number
    3006946279-2017-00099
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    May 4, 2017
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, THE SURGEON WAS UNABLE TO INSERT THE HUMERAL LINER INTO THE COROLLA. THE SURGEON REMOVED THE RINGLOC COMPONENT, SPREAD IT, AND REINSERTED, BUT THE LINER STILL WAS UNABLE TO SEAT. DURING SEVERAL ATTEMPTS TO INSERT, THE COROLLA MIGRATED. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE AND THE SAME COROLLA WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387750 UNKNOWN TESS HUMERAL INSERT PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention