BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRN II BCS LCK FEM IMPLANT IMPACT

    MDR report key: 24202650 · Received January 28, 2026

    Report

    Report Number
    1020279-2026-00126
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 28, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JHW
    UDI-DI
    00885556003541
    PMA / PMN Number
    K111711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE- (B)(4). H11 H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE. PATIENT WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259246 JRN II BCS LCK FEM IMPLANT IMPACT U.V. METHOD, CPK ISOENZYMES JHW SMITH & NEPHEW, INC. UNKNOWN 00885556003541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown