BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM

    MDR report key: 15590330 · Received October 12, 2022

    Report

    Report Number
    1038671-2022-01301
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    August 12, 2019
    Report Date
    April 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173393
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-010-01-0310 - LOGIC FEMORAL PS CEM RIGHT SZ 1, 4046922; 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T, 4059402; 200-02-32 - THREE PEG PATELLA 32MM, 4021542; A10012 - GPS IMPLANT KIT V2, 06038015015H7. RECALL NUMBER: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR.

    Additional Manufacturer Narrative · 0

    H11. CORRECTION - IT HAS BEEN DETERMINED BY ENGINEERING THAT THIS IS A DUPLICATE OF CASE, AS VERIFIED BY SN (B)(6), CAT # 02-012-44-1009. THIS CASE WILL BE CLOSED, AND ALL NEW INFORMATION WILL BE REPORTED IN MFR# 1038671-2019-00442.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2016. BEGINNING ABOUT ONE YEAR POST-OP THE PATIENT BEGAN TO EXPERIENCE NUMBNESS IN HER RIGHT KNEE. IN (B)(6) OF 2018 SHE BEGAN EXPERIENCING DULL PAIN, SWELLING, LOCKING/CATCHING, AND STIFFNESS. ATTEMPTS TO TREAT HER SYMPTOMS WITH HEAT/ICE, ELEVATION, AND NSAIDS WERE INEFFECTIVE. THE IMPLANTING SURGEON SUSPECTED FEMORAL LOOSENING DUE TO EARLY POLYTHYLENE WEAR. THE PATIENT WAS REVISED ON (B)(6) 2019. UPON EXPLANTATION OF THE DEVICES, THE SURGEON OBSERVED SIGNIFICANT GRANULATION TISSUE DUE TO POLYETHYLENE WEAR, AND NOTED "EXCESSIVE WEAR IN THE MEDIAL AND LATERAL COMPONENTS WHEN COMPARED TO NORMAL WEAR." THE FEMORAL COMPONENT WAS "COMPLETELY LOOSE" AND WAS REMOVED WITHOUT EFFORT. UPON INFORMATION AND BELIEF, THE POLYETHYLENE INSERT WAS DEFECTIVE, LEADING TO EARLY ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880408 LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-44-1009 10885862173393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10