BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    MDR report key: 15427196 · Received September 15, 2022

    Report

    Report Number
    1038671-2022-01123
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    March 17, 2016
    Report Date
    February 18, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001924
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION CONCOMITANT DEVICE(S): 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5 3905760, 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 3920801, 200-02-38 - THREE PEG PATELLA 38MM 2450956, 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 4061541, 204-70-00 - TIBIAL STEM EXT. SCREW 4065131, 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK 3911518, 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK 3977396, 3977428, A10012 - GPS IMPLANT KIT V2 05003015012.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, APPROXIMATELY 7 MONTHS POST OP THE INITIAL TSA, THIS 61 Y/O OBESE MALE PATIENT WAS REVISED DUE TO INFECTION. PATIENT WAS EXPERIENCING GRADUAL ONSET OF SWELLING, PAIN AND WARMTH IN RIGHT KNEE. ASPIRATE PRODUCED PURULENT FLUID. SURGEON PERFORMED IRRIGATION/DEBRIDEMENT AND INSERTION OF ABSORBABLE ANTIBIOTIC BEADS. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO OTHER INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 MONTHS POST OP THE INITIAL TSA, THIS 61 Y/O MALE PATIENT WAS REVISED DUE TO INFECTION. PATIENT WAS EXPERIENCING GRADUAL ONSET OF SWELLING, PAIN AND WARMTH IN RIGHT KNEE. ASPIRATE PRODUCED PURULENT FLUID. SURGEON PERFORMED IRRIGATION/DEBRIDEMENT AND INSERTION OF ABSORBABLE ANTIBIOTIC BEADS. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 MONTHS POST OP THE INITIAL TSA, THIS 61 Y/O OBESE MALE PATIENT WAS REVISED DUE TO INFECTION. PATIENT WAS EXPERIENCING GRADUAL ONSET OF SWELLING, PAIN AND WARMTH IN RIGHT KNEE. ASPIRATE PRODUCED PURULENT FLUID. SURGEON PERFORMED IRRIGATION/DEBRIDEMENT AND INSERTION OF ABSORBABLE ANTIBIOTIC BEADS. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426991 LOGIC TIBIA PS MOD INSRT SZ 5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-35-5009 UNK 10885862001924

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention SEE H10