BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESS HUM INSERT TH 6 DIA41 S2

    MDR report key: 6558412 · Received May 10, 2017

    Report

    Report Number
    3006946279-2017-00091
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 10, 2017
    Report Date
    October 30, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). MEDICAL PRODUCT - TESS HUM REVERSE COROLLA S2, CAT#: P1700434 LOT#: 0001054781. THIS DEVICE IS MANUFACTURED BY ZIMMER BIOMET FRANCE AND IS NOT CLEARED OR DISTRIBUTED 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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, IT WAS NOT POSSIBLE TO INSERT THE HUMERAL BEARING INTO THE REVERSE COROLLA. SO THE SURGEON REMOVED THE RINGLOC FROM THE COROLLA AND WAS THEN ABLE TO SEAT THE HUMERAL BEARING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340463 TESS HUM INSERT TH 6 DIA41 S2 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0000859863

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR