BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAL CUP IMPACTOR

    MDR report key: 6993549 · Received November 1, 2017

    Report

    Report Number
    6993549
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 25, 2017
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TOTAL HIP ARTHROPLASTY INSTRUMENT BROKE. ALL PIECES WERE RETRIEVED. MANUFACTURER RESPONSE: FOR THERMAL CUP IMPACTOR, THERMAL CUP IMPACTOR (PER SITE REPORTER). COMPANY REP WAS PRESENT DURING SURGICAL PROCEDURE AND OBTAINED ANOTHER IMPACTOR TO USE DURING THE REMAINING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773046 THERMAL CUP IMPACTOR IMPACTOR LXH SYNTHES (USA) PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NO OTHER THERAPIES