BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 3

    MDR report key: 16686919 · Received April 5, 2023

    Report

    Report Number
    1038671-2023-00591
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314543
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: M001753 02-022-35-3011 TRULIANT TIB IMP PS INSERT SZ 3 11MM. 5921116 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. 5873608 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: THE REVISION REPORTED IN (B)(4) WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND/OR PATIENT RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B6, B7, G3 FROM FU1-27 APR 2023, G6 FROM FU1-30 DAY, THE RIGHT KNEE WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMORAL COMPONENT AND RECALLED POLY. THE REVISION SURGERY WAS APPROXIMATELY 3 YEARS, 9 MONTHS, AFTER INITIAL IMPLANT. DUE TO THE RECALL THE DEVICE WILL NOT BE RELEASED BY THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. CORRECTED INFORMATION- FROM INITIAL MDR F6, F8 & F10 SHOULD BE BLANK- THIS IS A MANUFACTURER'S REPORT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF THE REPORTED LOSS OF RANGE OF MOTION AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, MAY HAVE LED TO LOOSENING AT THE CEMENT-BONE INTERFACE AND/OR CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED FROM THE PROVIDED IMAGES. 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, THE FEMALE PATIENT HAD AN INITIAL BILATERAL TKA ON (B)(6) 2019. THE PATIENT COMPLAINED OF PAIN AND HER RIGHT KNEE WAS REVISED ON (B)(6) 2023 DUE TO LOOSE FEMUR AND RECALLED POLY. THIS EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND THERE IS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799025 TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-020-11-0330 10885862314543

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention SEE H10