BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 18637116 · Received February 3, 2024

    Report

    Report Number
    1038671-2024-00150
    Event Type
    Injury
    Date Received
    February 3, 2024
    Date of Event
    April 12, 2022
    Report Date
    September 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304087
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-020-11-0320 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2: 5232250; 02-022-45-2020 - TRULIANT TIB FIT TRAY CEM SZ 2F / 2T: 5099979; 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: 5258072; 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE: 5249209; 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: 5221157; 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: 5221161; 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: 5221164.

    Additional Manufacturer Narrative · 0

    B3: OCCURRED IN 2022 - SPECIFIC DATE UNKNOWN. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. INSTABILITY IS A KNOWN RISK, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 70 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018 AND PRESENTED WITH LIGAMENT LAXITY 2 YEAR(S) AND 2 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2022. THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. RX'D HINGED KNEE BRACE FOR LIGAMENT LAXITY CAUSING SLIGHT BILATERAL OPENING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION OF PRESCRIBING A HINGED KNEE BRACE WAS TAKEN AND THE OUTCOME WAS RESOLVED ON (B)(6) 2022. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557397 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304087

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female SEE H10