BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS REVERSE HUMERAL INSERT

    MDR report key: 7340705 · Received March 15, 2018

    Report

    Report Number
    3006946279-2018-00102
    Event Type
    Injury
    Date Received
    March 15, 2018
    Report Date
    March 15, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). AS BIOMET FRANCE DID NOT RECEIVE ANY INFORMATION ABOUT THE INVOLVED BATCH NUMBER AND AS THE PRODUCT HAS NOT BEEN RETURNED, BIOMET FRANCE WAS NOT ABLE TO PERFORM ANY BATCH AND MANUFACTURING DOCUMENTATION REVIEW AND PRODUCT ANALYSIS COULD NOT BE PERFORMED. HOWEVER THIS EVENT IS CATEGORIZED AS A COMPLAINT AND COULD BE REOPENED IF FURTHER INFORMATION/PRODUCT IS RECEIVED LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN UNSTABLE RIGHT SHOULDER REVERSE TESS AND REQUIRED ADDITIONAL STABILITY (VIA ADDITIONAL OFFSET). THE SURGEON ASKED FOR A CUSTOM HUMERAL INSERT TO PERFORM A REVISION WITH THE CUSTOM HUMERAL INSERT TO INCREASE THE JOINT TENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186539 TESS REVERSE HUMERAL INSERT PROTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention