BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS GLENOID REVERSE HEAD DIAMETER 36

    MDR report key: 6061150 · Received October 27, 2016

    Report

    Report Number
    3006946279-2016-00403
    Event Type
    Injury
    Date Received
    October 27, 2016
    Report Date
    September 28, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PK040610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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 USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 K040610. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00402 / 00403).

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ANTERIOR SHOULDER REVISION FOR DEBRIDEMENT OF THE ROTATOR CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711928 TESS GLENOID REVERSE HEAD DIAMETER 36 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0000744403

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R