BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15923022 · Received December 6, 2022

    Report

    Report Number
    1038671-2022-01569
    Event Type
    Injury
    Date Received
    December 6, 2022
    Date of Event
    November 8, 2022
    Report Date
    February 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312679
    PMA / PMN Number
    K171045
    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: 02-020-14-0345 - TRULIANT CR POR FEM CR POR RIGHT SZ 4.5, 6724408, 02-022-55-4545 - TRULIANT POR TIB TRAY SIZE 4.5F/4.5T, 6869625, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6891722, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, S045140, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK, 5440117, S265331, 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK, S223293. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: THE REASON FOR THE PAIN AND SYNOVITIS LEADING TO THE REVISION REPORTED CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED, BUT DOES NOT APPEAR TO BE RELATED TO PROSTHESIS WEAR AS THE PROVIDED IMAGES DO NOT SHOW SIGNS OF WEAR THAT ARE INCONSISTENT WITH AN IMPLANTED DEVICE. CONTRIBUTING FACTORS TO THE REVISION MAY HAVE BEEN HIGH TENSION OF THE JOINT DURING FLEXION AND INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL.

    Description of Event or Problem · 0

    IT WAS REPORTED A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 3 MONTHS POST THE INITIAL PROCEDURE DUE TO PAINT AND SYNOVITIS. SOME MODERATE WEAR WAS NOTED PER SURGEON. THE KNEE WAS A LITTLE TIGHT IN FLEXION, SO RELEASES WERE PERFORMED AND A THINNER SIZE 9MM INSERT WAS USED WITH GOOD ROM AND STABILITY. THE PATIENT LEFT IN STABLE CONDITION. EXPLANT NOT AVAILABLE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961008 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM UNK 10885862312679

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10