BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESS HUM INSERT TH 6 DIA36 S0

    MDR report key: 6221409 · Received January 4, 2017

    Report

    Report Number
    3006946279-2017-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    November 30, 2016
    Report Date
    June 14, 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 USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT MEDICAL PRODUCT - TESS HUMERAL REVERSE COROLLA S0, CATALOG#: P1700430 LOT#: 0001125332. THERAPY DATE - (B)(6) 2016. 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3006946279-2017-00002 / 00003). IT IS UNKNOWN WHICH DEVICE WAS IMPLANTED DURING THIS PROCEDURE AND WHICH WAS DISCARDED.

    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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, IT WAS OBSERVED THAT AMONG ALL THE TESS HUMERAL REVERSE COROLLA, THE SMALLER SIZES ARE LESS FLEXIBLE. THEREFORE THE INSERTION OF THE TESS HUMERAL INSERT IS NOT THAT SIMPLE. FURTHER INVESTIGATION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. 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

    DURING A SHOULDER ARTHROPLASTY, THE HUMERAL INSERT WOULD NOT SEAT INTO THE REVERSE COROLLA. THE LOCKING RING WAS REMOVED AND THEN THE HUMERAL INSERT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6891 TESS HUM INSERT TH 6 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001127265

    Patients

    Seq Age Sex Outcome Treatment
    1