BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUMERAL REVERSED INLAY 036 S1 12MM

    MDR report key: 6316075 · Received February 9, 2017

    Report

    Report Number
    3006946279-2017-00029
    Event Type
    Injury
    Date Received
    February 9, 2017
    Report Date
    April 20, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    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 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A SHOULDER REVISION DUE TO INSTABILITY AND RECURRENT DISLOCATIONS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98695 TESS HUMERAL REVERSED INLAY 036 S1 12MM PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 781967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention