BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESS HUMERAL INSERT TH 6 DIA36 S0

    MDR report key: 6331816 · Received February 15, 2017

    Report

    Report Number
    3006946279-2017-00032
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 15, 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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060694.

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROPLASTY, THE HUMERAL INSERT HAD DIFFICULTY INSERTING INTO THE COROLLA. THE RINGLOCK WAS REMOVED, ADJUSTED AND REINSERTED WHICH THEN ALLOWED FOR THE HUMERAL INSERT TO PROPERLY FIT INTO THE COROLLA WITH MINIMAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114306 TESS HUMERAL INSERT TH 6 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 1127265

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR