BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN GENESIS II TOTAL KNEE TIB BASEPLATE

    MDR report key: 19103049 · Received April 14, 2024

    Report

    Report Number
    1020279-2024-00752
    Event Type
    Injury
    Date Received
    April 14, 2024
    Date of Event
    June 28, 2023
    Report Date
    May 23, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). SECTION H6 (HEALTH EFFECT - CLINICAL CODE) WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4). ¿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. DOI: DOI.ORG/10.3390/JCM12134356. CARULLI, C., INNOCENTI, M., TAMBASCO, R., PERRONE, A., & CIVININI, R. (2023). TOTAL KNEE ARTHROPLASTY IN HAEMOPHILIA: LONG-TERM RESULTS AND SURVIVAL RATE OF A MODERN KNEE IMPLANT WITH AN OXIDIZED ZIRCONIUM FEMORAL COMPONENT. JOURNAL OF CLINICAL MEDICINE, 12(13), 4356.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "TOTAL KNEE ARTHROPLASTY IN HAEMOPHILIA: LONG-TERM RESULTS AND SURVIVAL RATE OF A MODERN KNEE IMPLANT WITH AN OXIDIZED ZIRCONIUM FEMORAL COMPONENT", 1 PATIENT, DUE TO RECURRENT BLEEDINGS, HAD AN EARLY MECHANICAL LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT 4 YEARS AFTER A TKA PROCEDURE USING GENESIS LL IMPLANT SYSTEM. THIS ISSUE WAS SOLVED WITH A REVISION SURGERY WITH CEMENTLESS STEMS AND A HIGHER CONSTRAINT IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793414 UNKN GENESIS II TOTAL KNEE TIB BASEPLATE PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention