BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    MDR report key: 15921175 · Received December 5, 2022

    Report

    Report Number
    1038671-2022-01565
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    October 25, 2021
    Report Date
    January 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173638
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL DEVICES: 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4, 3807135, 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T, 3940393, OPTETRAK 3-PEG PATELLA. CORRECTION/REMOVAL NUMBER: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOSS OF RANGE OF MOTION, FEMORAL LOOSENING, AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. 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, THIS MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2016. GRADUALLY, THE PATIENT BEGAN TO EXPERIENCE PAIN, STIFFNESS, SWELLING, EFFUSION, AND DECREASED RANGE OF MOTION. AN X-RAY WAS TAKEN ON OR ABOUT (B)(6) 2021 AND REVEALED OSTEOLYSIS OF THE LEFT TIBIA. THE PATIENT WAS REVISED ON (B)(6) 2021. UPON EXPLANTATION, THE SURGEON FOUND SIGNIFICANT GRANULATION TISSUE CONSISTENT WITH POLYETHYLENE WEAR AND THE TIBIAL INSERT WAS SIGNIFICANTLY WORN BOTH MEDIALLY AND LATERALLY WITH DELAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514284 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-44-4009 10885862173638

    Patients

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