BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15777542 · Received November 10, 2022

    Report

    Report Number
    1038671-2022-01452
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 24, 2022
    Report Date
    April 22, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307873
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 5668016 02-020-13-0250 - TRULIANT CR CEM FEM CR CEM LEFT SZ 5. 5527540 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T. 5586943 200-02-38 - THREE PEG PATELLA 38MM. 5758114 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. S009495 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. S009967 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. S009989 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. S004738 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK. S004875 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK. S004876 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK. 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 SUBSEQUENT REVISION FOR PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT RELATED CONDITIONS.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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

    IT WAS REPORTED THAT A MALE PATIENT, HAD AN INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN AND SYNOVITIS. A NEW 9MM CRC INSERT WAS IMPLANTED AND HAD GOOD RANGE OF MOTION AND STABILITY AFTER SOME RELEASES WERE PERFORMED. THERE WERE NO REPORTED ISSUES DURING THE REVISION SURGICAL PROCEDURE. MINIMAL WEAR WAS NOTED BY THE SURGEON. THE PATIENT LEFT IN STABLE CONDITION. EXPLANTS ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE FROM THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516254 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 5, 9MM UNK 10885862307873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention