BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENT

    MDR report key: 22798797 · Received August 13, 2025

    Report

    Report Number
    1038671-2025-02749
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    April 13, 2022
    Report Date
    September 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-14-0235 - TRULIANT CR POR FEM CR POR LEFT SZ 3.5: 6871415. 02-022-51-3511 - TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM: 7209347. 02-022-55-3535 - TRULIANT POR TIB TRAY SIZE 3.5F/3.5T: 7000168. 180-65-35 - ALTEON 6.5MM SCREW, 35MM: S248769. 180-65-35 - ALTEON 6.5MM SCREW, 35MM: S248778. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: 7088078. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK: 7223176. 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK: S337409. 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK: S337665. 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK: S337797. 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK: 5318129. A10012 - GPS IMPLANT KIT V2: 08000121154. 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 DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REPORTED REVISION DUE TO STIFFNESS AND ARTHROFIBROSIS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO PATIENT FACTORS/ETIOLOGY, COMPONENT POSITIONING, ARTHROFIBROSIS, INFECTION AND/OR IMPLANT SELECTION. THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, AND RADIOGRAPHS 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 A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, 5 WEEKS LATER, THE PATIENT EXPERIENCED PAIN AND STIFFNESS/ARTHROFIBROSIS (10 TO 110 DEGREES). AS A RESULT, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624794 TRULIANT KNEE COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization SEE H11.