BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN GENESIS UNI KNEE IMPL

    MDR report key: 21998659 · Received May 9, 2025

    Report

    Report Number
    1020279-2025-00826
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    July 2, 2024
    Report Date
    May 9, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: CASE (B)(4). ANDRIOLLO L, MONTAGNA A, MAZZELLA GG, SANGALETTI R, BENAZZO F, ROSSI SMP. NAVIGATED VERSUS CONVENTIONAL MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: MINIMUM 18 YEARS CLINICAL OUTCOMES AND SURVIVORSHIP OF THE ORIGINAL CARTIER DESIGN. KNEE. 2024 AUG;49:183-191. DOI: 10.1016/J.KNEE.2024.07.009. EPUB 2024 JUL 22. PMID: 39043013. 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 "NAVIGATED VERSUS CONVENTIONAL MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: MINIMUM 18 YEARS CLINICAL OUTCOMES AND SURVIVORSHIP OF THE ORIGINAL CARTIER DESIGN", 47 MONTHS AFTER A PRIMARY UKA SURGERY IN WHICH A GENESIS UNI SYSTEM WAS IMPLANTED BETWEEN (B)(6) 2003 TO (B)(6) 2006; ONE (1) PATIENT SUSTAINED REVISION SURGERY FOR ASEPTIC LOOSENING. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881109 UNKN GENESIS UNI KNEE IMPL PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H