BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER LT

    MDR report key: 17790077 · Received September 21, 2023

    Report

    Report Number
    1020279-2023-01820
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 30, 2023
    Report Date
    October 2, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556422878
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA H10: FURTHER REVIEW OF THIS CASE INDICATES THIS IS A DUPLICATE REPORT. THE EVENT IN THIS REPORT HAS BEEN ALREADY REPORTED UNDER MDR NO. 1020279-2023-01848. ALL FURTHER COMMUNICATION FOR THIS EVENT WILL BE MANAGED IN THAT CASE, INCLUDING A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION. WE RESPECTFULLY REQUEST TO CLOSE THE CASE AS A DUPLICATE AND REFER TO THE REFERENCED CASE ABOVE.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TKA SURGERY, A JRNY II CR LKG FEM IMP BUMPER LT BROKE IN HALF WHILE IMPACTING. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061540 JRNY II CR LKG FEM IMP BUMPER LT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 12FBG0002 00885556422878

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown