BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY II CR FEM OX NP LT SZ 3

    MDR report key: 25331604 · Received May 29, 2026

    Report

    Report Number
    1020279-2026-00715
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    February 25, 2025
    Report Date
    May 29, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556422809
    PMA / PMN Number
    K121443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT 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 CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR 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, AFTER A REVISION TKA SURGERY WAS PERFORMED ON (B)(6) 2025 BECAUSE OF A LOOSE/MISALIGNED IMPLANT (ZIMMER BIOMET), THE PATIENT EXPERIENCED DIFFICULTY BEARING WEIGHT AND PAIN, AND THIS BECAME WORSE IN (B)(6) 2025. X-RAYS SHOWED LOOSE BODIES AND BONE SCAN FAVORED LOOSENING. TESTING WAS NEGATIVE FOR INFECTION AND ALLERGY TESTING WAS NEGATIVE WITH EXCEPTION OF NICKEL, BUT THE IMPLANT WAS NICKEL FREE. THIS ADVERSE EVENT WAS TREATED BY A LIDOCAINE INJECTION INTO BURSA ON (B)(6) 2025 AND A GAE WILL BE PERFORMED ON (B)(6) 2026. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD EXCEPT SEVERE PAIN WITH TKR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468545 JRNY II CR FEM OX NP LT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 24HM04327 00885556422809

    Patients

    Seq Age Sex Outcome Treatment
    1