BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN JOURNEY PFJ KNEE IMPL

    MDR report key: 22577721 · Received July 23, 2025

    Report

    Report Number
    1020279-2025-01273
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    May 31, 2024
    Report Date
    July 23, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KRR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). PACCHIAROTTI G, TODESCA A, COPPOLA M, GUMINA S. ROBOTIC-ASSISTED PATELLOFEMORAL ARTHROPLASTY PROVIDES EXCELLENT IMPLANT SURVIVORSHIP AND HIGH PATIENT SATISFACTION AT MID-TERM FOLLOW-UP. INT ORTHOP. 2024 AUG;48(8):2055-2063. DOI: 10.1007/S00264-024-06224-2. EPUB 2024 MAY 31. PMID: 38819666; PMCID: PMC11246259. THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE 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 CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL 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 ON LITERATURE REVIEW " ROBOTIC-ASSISTED PATELLOFEMORAL ARTHROPLASTY PROVIDES EXCELLENT IMPLANT SURVIVORSHIP AND HIGH PATIENT SATISFACTION AT MID-TERM FOLLOW-UP", AFTER A ROBOTIC ASSISTED PATELLOFEMORAL KNEE ARTHROPLASTY SURGERY IN WHICH A JOURNEY PATELLOFEMORAL DEVICE WAS IMPLANTED BETWEEN JANUARY 2018 AND JANUARY 2021; ONE (1) PATIENT SUSTAINED REVISION SURGERY WITH CONVERSION TO THA DUE TO OSTEOARTHRITIS PROGRESSION AFTER FIVE (5) YEARS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784594 UNKN JOURNEY PFJ KNEE IMPL PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER KRR SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R