BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT POR TIB TRAY SIZE 4.5F/3.5T

    MDR report key: 15666313 · Received October 25, 2022

    Report

    Report Number
    1038671-2022-01346
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    October 6, 2022
    Report Date
    February 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862317216
    PMA / PMN Number
    K182346
    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

    CONCOMITANT PRODUCTS: TRULIANT PS POR FEM PS POR RIGHT SZ 4.5 (CAT# 02-020-12-0345 / SERIAL# (B)(4)); TRULIANT TIB IMP PS INSERT SZ 4.5 9MM (CAT# 02-022-35-4509 / SERIAL# (B)(4)); ADVANCED PATELLA 32MM 3 PEG IMPLANT (CAT# 200-07-32 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) 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. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF ¿LOOSENING¿ IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE DEVICE AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL TKA, THE 64 Y/O FEMALE 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
    2894731 TRULIANT POR TIB TRAY SIZE 4.5F/3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT POR TIB TRAY SIZE 4.5F/3.5T UNK 10885862317216

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention