BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM

    MDR report key: 17265611 · Received July 6, 2023

    Report

    Report Number
    1038671-2023-01555
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 13, 2023
    Report Date
    March 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174314
    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

    PENDING INVESTIGATION. D10: 2141597 - 02-010-03-0200 - LOGIC CR CEMENT FEMORAL LEFT, 0 4716377 - 02-012-45-0000 - LOGIC FIT CEMENT TIVIAL TRAY 0F/0T 6000017114 - A10012 - GPS DISPOSABLE KIT 842660 - TN190-119-05 - OSCILLATING BLADE M-CLASS 19X1.19X105 812591 - TN193-119-90 - OSCILLATOR BLADE M-CLASS 19/13X 1.19X90MM UNASSIGNED - Z99007 - LOGIC TKA SET UNASSIGNED - ZINFO-01 - INFORMATION FEE UNASSIGNED - ZOSCL-01 - OSCILLATOR JAV STREAMING OSCILLATOR UNASSIGNED - ZREAM-01 - REAMER H7: Z-0021-20220.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF KNEE INSTABILITY AND OVERALL TIBIAL SLOPE THAT ALLOWED FOR EXCESSIVE POSTERIOR AND MEDIAL CONTACT LEADING TO WEAR OF THE POLYETHYLENE TIBIAL INSERT. A CONTRIBUTING FACTOR TO THE EXTENT OF WEAR ON INSERT MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR FIVE YEARS.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 CLINICAL CODE AND COMPONENT CODE. ADDITIONAL INFORMATION: H6 PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF KNEE INSTABILITY AND OVERALL TIBIAL SLOPE THAT ALLOWED FOR EXCESSIVE POSTERIOR AND MEDIAL CONTACT LEADING TO WEAR OF THE POLYETHYLENE TIBIAL INSERT. A CONTRIBUTING FACTOR TO THE EXTENT OF WEAR ON INSERT MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR FIVE YEARS. 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 COMPLAINED OF KNEE SWELLING AND PAIN AND THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE SURGEON DID NOT FIND METALLOSIS. HE DECIDED THAT NO PROBLEM OF THE LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND AND REMOVED ALL PROLIFERATIVE TISSUE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786656 LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-49-2009 10885862174314

    Patients

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