BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS GLEN REVERSED HEAD DIA36

    MDR report key: 5678086 · Received May 25, 2016

    Report

    Report Number
    3006946279-2016-00094
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 28, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    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. THE NECESSARY MANUFACTURING HISTORY TO REVIEW 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 (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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00093 & 00094).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE REVIEW OF MANUFACTURING DHR SHOWS THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. THE PRODUCT INSPECTION REVEALS THAT THE PRODUCT IS CONFORMED TO THE PREDEFINED SPECIFICATIONS. AS THE INSERT AND THE BASEPLATE HAVE NOT BEEN RETURNED, THE INCIDENT COULD NOT BE DETERMINED. ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE INCIDENT CAN'T BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED SEVEN DAYS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE HUMERAL HEAD FROM THE BASEPLATE. THE HUMERAL HEAD AND INSERT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333790 TESS GLEN REVERSED HEAD DIA36 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001088060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R