BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM

    MDR report key: 20553196 · Received October 28, 2024

    Report

    Report Number
    1038671-2024-04157
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 15, 2024
    Report Date
    January 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144331
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INFECTION, AS STATED IN THE EXPERIENCE REPORT. THE WEAR WAS LIKELY DUE TO MALALIGNMENT BETWEEN THE FEMORAL COMPONENT AND TIBIAL TRAY WHICH LED TO PROSTHESIS WEAR OF THE TIBIAL INSERT. THE REASON FOR THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED, BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED AND POSSIBLE CONTRIBUTIONS FROM PATIENT RELATED CONSIDERATIONS COULD NOT BE ASSESSED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION AND SUFFICIENT CLINICAL INFORMATION WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): Z99007 - LOGIC TKA UNASSIGNED. ZINFO-01 - UNASSIGNED. ZOSCL-01 - UNASSIGNED. ZREAM-01 - UNASSIGNED. TN190-119-05 - M-CLASS 19X1.19X105 (B)(6). 02-012-47-1509 - LOGIC CR 1.5 - 9MM 4132885. 200-02-32 - 3 / 32MM (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS 5 MONTHS POST OP. THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY USING CR SDT TIBIAL INSERT WHICH STARTED CAUSING KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE INFECTION AND WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT WAS PERFORMED. WEAR ON POSTERIOR SIDE WAS OBSERVED. SURGEON DECIDED TO REPLACED TO A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929499 LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862144331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11