BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESS HUM INSERT TH 6 DIA36 S1

    MDR report key: 6384901 · Received March 7, 2017

    Report

    Report Number
    3006946279-2017-00050
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    January 12, 2017
    Report Date
    March 5, 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET U.S. 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, IT WAS NOT POSSIBLE TO IMPLANT THE HUMERAL INSERT INTO THE COROLLA. THERE WAS NO PATIENT INJURY OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167713 TESS HUM INSERT TH 6 DIA36 S1 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 1119065

    Patients

    Seq Age Sex Outcome Treatment
    1