BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15777477 · Received November 10, 2022

    Report

    Report Number
    1038671-2022-01443
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 17, 2022
    Report Date
    February 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305282
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    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: 6214432, 02-020-11-0340, TRULIANT PS CEM FEM PS CEM RIGHT SZ 4, 6455538, 02-022-45-4040, TRULIANT TIB FIT TRAY CEM SZ 4F / 4T, 6436356, 200-02-38, THREE PEG PATELLA 38MM, 6494320, 201-78-15, HOLDING PIN MINI SHARP POINT 4 PK, S042345, 521-78-23, THREADED PIN SIZE 2.3 COLLARED 2PK, S064280, 521-78-23, THREADED PIN SIZE 2.3 COLLARED 2PK, S049576, 521-78-32, THREADED PIN SIZE 3.0 COLLARLESS 2PK, S051317, 521-78-32, THREADED PIN SIZE 3.0 COLLARLESS 2PK, S039400, 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 PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY PATIENT-RELATED CONDITIONS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND/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 60 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN, STIFFNESS AND SYNOVITIS. HE WAS REVISED FROM AN 11MM PSC INSERT TO A 9MM CRC WITH GOOD ROM AND STABILITY. THE INSERT HAD NO VISUAL DAMAGE EXCEPT FOR WHAT INCURRED FROM USING THE OSTEOTOME FOR REMOVAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878903 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 11MM UNK 10885862305282

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention