BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS POR FEM PS POR LEFT SZ 3.5

    MDR report key: 15419116 · Received September 14, 2022

    Report

    Report Number
    1038671-2022-01112
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 24, 2022
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    MBH
    UDI-DI
    10885862314796
    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

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 6739119, 02-020-12-0235 - TRULIANT PS POR FEM PS POR LEFT SZ 3.5; 6030524, 02-022-55-3525 - TRULIANT POR TIB TRAY SIZE 3.5F/25T; ;6982635, 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING, OSTEOLYSIS, AND PAIN. HOWEVER THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND PRE-REVISION RADIOGRAPHS WERE UNABLE TO BE OBTAINED. H7: Z-0023-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE PATIENT COMPLAINED OF SEVER PAIN, A POSSIBLE LOOSE FEMUR, AND WAS REVISED TO A COMPETITOR'S PRODUCT. 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
    2667909 TRULIANT PS POR FEM PS POR LEFT SZ 3.5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED MBH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM 10885862314796
    986911 TRULIANT PS POR FEM PS POR LEFT SZ 3.5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED MBH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM 10885862314796

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention SEE H10