BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GENESIS II TOTAL KNEE IMPLANT

    MDR report key: 19084257 · Received April 10, 2024

    Report

    Report Number
    1020279-2024-00723
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    August 26, 2023
    Report Date
    April 10, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). CAKMAK, M. F., & HOROZ, L. (2023). THE EXAMINATION OF THE BENEFITS OF THE USAGE OF BARBED, KNOTLESS SUTURE IN CAPSULE REPAIR DURING TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED CONTROLLED STUDY. INDIAN JOURNAL OF ORTHOPAEDICS, 57(11), 1881-1890. HTTPS://DOI.ORG/10.1007/S43465-023-00976-6. 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 "THE EXAMINATION OF THE BENEFITS OF THE USAGE OF BARBED, KNOTLESS SUTURE IN CAPSULE REPAIR DURING TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED CONTROLLED STUDY" AFTER A TKA WHERE A GENESIS II SYSTEM WAS IMPLANTED, A PATIENT DEVELOPED PERI-PROSTHETIC JOINT INFECTION. IT IS UNKNOWN HOW THIS WAS TREATED, CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230957 UNKNOWN GENESIS II TOTAL KNEE IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention