BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM

    MDR report key: 19256301 · Received May 6, 2024

    Report

    Report Number
    1038671-2024-01072
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 11, 2024
    Report Date
    August 23, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144379
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR AND DELAMINATION MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. HOWEVER, THIS COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: H6 CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5624696 - 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5 5634363 - 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T (B)(6) - 02-012-48-1509 - LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM 11015018037 - (B)(6) - GPS DISPOSABLE KIT 934061.

    Description of Event or Problem · 0

    AS REPORTED, THE 76 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. 5 YEARS LATER, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND THE PATIENT WAS REVISED ON (B)(6) 2024. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE SURGEON DID NOT FIND METALLOSIS. THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. POLYETHYLENE PARTICLES AND ALL PROLIFERATIVE TISSUE WAS REMOVED AND THE INSERT WAS REPLACED TO A NEW CR 9MM. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621242 LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862144379

    Patients

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