BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESS SHOULDER PROSTHESIS REVERSED HUMERAL INSERT TH 8 DIA36 S0

    MDR report key: 6507134 · Received April 20, 2017

    Report

    Report Number
    3006946279-2017-00076
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 21, 2017
    Report Date
    April 20, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCT - TESS HUM REVERSE COROLLA S0, CAT#: P1700430 LOT#: 0001151822. 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006946279-2017-00075 - 00076.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, IT WAS DIFFICULT TO INSERT THE HUMERAL INSERT INTO THE COROLLA. THE SURGEON ATTEMPTED TO IMPACT WITH A MALLET, WHICH CAUSED THE COROLLA MIGRATE SLIGHTLY LATERAL, BUT IT STILL WOULD NOT SEAT. A SECOND INSERT OF A DIFFERENT SIZE WAS ATTEMPTED WITH THE SAME RESULTS. THE SURGEON THEN REMOVED THE LOCKING RING, SPREAD IT OUT, AND REINSERTED IT IN THE COROLLA. THE INSERT THEN SAT PROPERLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290103 TESS SHOULDER PROSTHESIS REVERSED HUMERAL INSERT TH 8 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001172382

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR