BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LGN TIB CONE IMPCTR HNDL 4MM OFFST SLEEV

    MDR report key: 23349548 · Received October 21, 2025

    Report

    Report Number
    1020279-2025-01740
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 24, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556537176
    PMA / PMN Number
    K162775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: REPORT NUMBER 1020279-2025-01740 (INTERNAL REFERENCE: CASE-(B)(4)) WAS FOUND TO BE A DUPLICATE OF REPORT NUMBER 1020279-2025-01746 (INTERNAL REFERENCE: CASE-(B)(4)); THEREFORE, THE CASE CASE-(B)(4) WILL BE CLOSED IN OUR SYSTEM. FURTHER DETAILS REGARDING THIS EVENT WILL BE PROVIDED UNDER REPORT NUMBER 1020279-2025-01746.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS 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 CONSERVATIVELY 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 LEGION REVISION SURGERY IN THE LEFT KNEE, IT WAS NOTICED THAT ONE (1) LGN TIB CONE IMPCTR HNDL 4MM OFFST SLEEV WAS NOT INSERTING IN ONE (1) LGN CONE IMPACTOR HANDLE. THE SLEEVE WAS NOT DEPRESSING, NOR ENGAGING IN THE HANDLE, IT WOULDN'T FULLY SEAT. IT HAD TO HIT THE SLEEVE TO GET IT TO ENGAGE IN THE BROACH HANDLE. AFTER HITTING THE SLEEVES A NUMBER OF TIMES, THE SURGEON MANAGED TO SEAT THE SLEEVE IN THE CONE BROACH HANDLE. DUE TO HOWEVER IMPACTING THE SLEEVE INTO THE BROACH HANDLE SO HARD IT BECAME WELDED IN THE BROACH HANDLE WHICH RESULTED IN THE 4MM SLEEVE GETTING STUCK. LATER ON IN THE SURGERY, WHEN PREPARING THE FEMUR, IT WAS NEEDED FEMORAL CONES FOR METAPHYSEAL FIXATION. AS NO OFFSET CAN BE USED WITH CONES, THE 4MM OFFSET BEING STUCK IN THE BROACH HANDLE WAS A SERIOUS PROBLEM. THE SURGEON AGAIN MANAGED TO HAMMER THE SLEEVE OUT. DUE TO THE BROACH HANDLE BEING FAULTY AND ONE (1) LGN CONE IMPCTR HNDL NEUTRAL SLEEVE ALSO NOT DEPRESSING INTO THE HANDLE, THE SURGEON HAD TO BROACH AND INSERT TRIAL AND DEFINITIVE IMPLANT USING THE BROACH WITHOUT A SLEEVE. THE PROCEDURE WAS COMPLETED, AFTER A DELAY OF ONE HOUR, USING THE SAME DEVICES. THIS EVENT INCREASED THE LENGTH OF ANESTHESIA BY APPROXIMATELY AN HOUR. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999425 LGN TIB CONE IMPCTR HNDL 4MM OFFST SLEEV PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 17EGA0013 00885556537176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 71442011/18ESC0045/LGN CONE IMPACTOR HANDLE| 71442012/17GGA0064/LGN TIB CONE IMPCTR HNDL 2MM OF| 71442018/17GGA0019/LGN CONE IMPCTR HNDL NEUTRAL SL