BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 9MM

    MDR report key: 15545378 · Received October 5, 2022

    Report

    Report Number
    1038671-2022-01246
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    December 3, 2019
    Report Date
    March 30, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304254
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 5040728, 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T 5370290, 200-02-32 - THREE PEG PATELLA 32MM 5337055, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5422977, 203-96-64 - SAWBLADES EZ1913.M62 90X19, 1.27MM STRKR5/6/7 234796.

    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 DUE TO PATIENT RELATED CONDITIONS. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 5 MONTHS POST OP THE INITIAL RIGHT TKA, THIS 70 Y/O OBESE FEMALE PATIENT WAS REVISED DUE TO INFECTION ON (B)(6) 2019. THE PATIENT HAD DRAINAGE FROM HER KNEE SO SHE WENT TO THE ED ON (B)(6) 2019. ASPIRATION SHOWED STAPH AUREUS THE WOUND WAS STILL DRAINING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONTINUING. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 5 MONTHS POST OP THE INITIAL RIGHT TKA, THIS 70 Y/O FEMALE PATIENT WAS REVISED DUE TO INFECTION. I&D WITH POLY EXCHANGE 7/23/19 WITH SURGEON WITH 6 WEEKS IV ANTIBIOTICS FOR SEPTIC TKA. ON BACTRIM DS. HAD ABSCESS I&D BY SURGEON 3 WEEKS AGO. SHE HAD DRAINAGE SO SHE WENT TO ED (B)(6) 2019. ASPIRATION STAPH AUREUS. WOUND STILL DRAINING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONTINUING.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 5 MONTHS POST OP THE INITIAL RIGHT TKA, THIS 70 Y/O OBESE FEMALE PATIENT WAS REVISED DUE TO INFECTION ON (B)(6) 2019. THE PATIENT HAD DRAINAGE FROM HER KNEE SO SHE WENT TO THE ED ON (B)(6) 2019. ASPIRATION SHOWED STAPH AUREUS THE WOUND WAS STILL DRAINING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONTINUING. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555238 TRULIANT TIB IMP PS INSERT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-35-3009 UNK 10885862304254

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention SEE H10