BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM

    MDR report key: 17393992 · Received July 25, 2023

    Report

    Report Number
    1038671-2023-01771
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174536
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4 4868982. 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 4874900. 200-02-35 - THREE PEG PATELLA 35MM 5027321. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO THE REPORTED INSTABILITY AND PROSTHESIS WEAR, WHICH ULTIMATELY LED TO DEVICE FRACTURE, AND INCLUSION OF THE POLYETHYLENE IMPLANTS IN THE PACKAGING RECALL. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE MALALIGNMENT BETWEEN IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. PROSTHESIS WEAR OF THE PATELLA COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESIS. 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 PATIENT HAD AN INITIAL LEFT TKA ON (B)(6), 2017. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT WAS REVISED ON (B)(6), 2023 AND THE POLY INSERT AND PATELLA WERE SWAPPED. THE POLY TIBIAL INSERT WAS BROKEN IN PIECES POSTERIORLY AND THOSE PIECES WERE REMOVED AND THE KNEE JOINT WAS IRRIGATED. ALL FRAGMENTS, PARTS, OR PIECES WERE REMOVED. 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
    653890 LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 10885862174536

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention SEE H10