BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER RT

    MDR report key: 20035089 · Received August 22, 2024

    Report

    Report Number
    1020279-2024-01634
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 5, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556085233
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    B5 ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION RECEIVED CONFIRMED THAT THE DEVICE BROKE AFTER SURGERY. THE REASSESSMENT DETERMINED THAT THE ISSUE DOES NOT MEET THE THRESHOLD FOR REPORTING AND THEREFORE, IT IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED, OUR FILES WILL BE UPDATED ACCORDINGLY, AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING IMPLANTATION IN A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED THAT ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE. SINCE THE INCIDENT OCCURRED AFTER THE PROCEDURE, THE PATIENT WAS NO LONGER INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24863 JRNY II CR LKG FEM IMP BUMPER RT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 15HBG0046 00885556085233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown