BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCORD TENSIONER

    MDR report key: 10596630 · Received September 28, 2020

    Report

    Report Number
    1020279-2020-04917
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 29, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    UDI-DI
    03596010485359
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE RE-ASSESSMENT DETERMINED THAT THIS COMPONENT IS A CONCOMITANT DEVICE FOR AN EVENT ALREADY REPORTED TO FDA UNDER 1020279-2020-04879 AND, THEREFORE, IT DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SPRING OF THE ACCORD TENSIONER BROKE AND FALL OUTSIDE THE PATIENT WOUND; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061167 ACCORD TENSIONER PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. 71360020 UNKNOWN 03596010485359

    Patients

    Seq Age Sex Outcome Treatment
    1