BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS POR FEM PS POR RIGHT SZ 4.5

    MDR report key: 24456156 · Received February 26, 2026

    Report

    Report Number
    1038671-2026-00193
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    October 6, 2022
    Report Date
    February 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314925
    PMA / PMN Number
    K181794
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5316760 02-022-35-(B)(6) - TRULIANT TIB IMP PS INSERT SZ 4.5 9MM. 5758187 02-020-12-(B)(6) - TRULIANT PS POR FEM PS POR RIGHT SZ 4.5. 6022415 02-022-55-(B)(6) - TRULIANT POR TIB TRAY SIZE 4.5F/3.5T. 6857967 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE, POOR BONE QUALITY, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING AND PAIN. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND PRE-REVISION RADIOGRAPHS WERE UNABLE TO BE OBTAINED. 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, APPROXIMATELY 1.5 YEARS POST INITIAL TKA, THE PATIENT HAD PAIN STARTING A FEW WEEKS AFTER SURGERY. PATIENT IS DISSATISFIED WITH IMPLANT FUNCTION. TIBIA WAS LOOSE WITH ONLY FIBROUS INGROWTH. FEMUR ALSO HAD MINIMAL BONE INGROWTH. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS AND X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520384 TRULIANT PS POR FEM PS POR RIGHT SZ 4.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314925

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R SEE H11.