BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15756270 · Received November 8, 2022

    Report

    Report Number
    1038671-2022-01427
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 10, 2022
    Report Date
    February 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304278
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 3756889, 208-05-03, CC DISTAL FEM AUGMENT SZ 3, 5MM 3900323, 208-05-03, CC DISTAL FEM AUGMENT SZ 3, 5MM 4867320, 02-012-61-6000, LOGIC OFFSET STEM EXT COUPLER 6MM 5045456, 02-010-06-0531, LOGIC POST. AUG. BLOCK SIZE 3, 5MM 5126743, 02-010-06-0330, LOGIC CC FEMORAL SIZE 3, RIGHT 5179770, 02-012-45-3020, LGC TIBIAL FIT TRAY CEM SZ 3F / 2T 5218705, 02-012-61-2000, LOGIC OFFSET STEM EXT COUPLER 2MM 5233057, 204-70-00, TIBIAL STEM EXT. SCREW 5245990, 02-012-60-1425, LOGIC STEM EXT 14MM X 25MM 5245997, 02-012-60-1425, LOGIC STEM EXT 14MM X 25MM 5282342, 02-010-06-0531, LOGIC POST. AUG. BLOCK SIZE 3, 5MM. H6: 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 PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY PATIENT-RELATED CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR MEDIAL KNEE PAIN. IT WAS NOTED THERE WAS SOME SYNOVITIS AND SCAR TISSUE MEDIAL. A THICKER INSERT WAS SELECTED AFTER TRIALING. THE ORIGINAL PS INSERT WAS 11MM. A 13MM WAS IMPLANTED WITH GOOD STABILITY AND RANGE OF MOTION. IT WAS STATED THAT THE POLY HAD NO VISUAL DAMAGE UPON REMOVAL. THE EXPLANTS NOT AVAILABLE TO THE SALES REP. THE PATIENT LEFT IN STABLE CONDITION. NO PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124464 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM UNK 10885862304278

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention