BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 17605345 · Received August 23, 2023

    Report

    Report Number
    1038671-2023-02026
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    August 15, 2022
    Report Date
    January 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER D10. CONCOMITANTS ¿ OPTETRAK LOGIC FEMORAL COMPONENT PS (02-010-01-0330, 4311922) ¿ OPTETRAK TIBIAL TRAY TRAPEZOID (02-012-41-3030, 4282593) ¿ OPTETRAK 3 PEG PATELLA (200-02-32, 4230691) THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION. NO OTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND INSTABILITY. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND INSTABILITY COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, AND COMPONENT LOOSENING. REVISION OPERATIVE REPORT OF (B)(6) 2022- PREOPERATIVE DIAGNOSIS- RIGHT KNEE FAILURE OF TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE WEAR. INDICATIONS: THE PATIENT HAD NOTED THAT SHE HAS PROGRESSIVE FELLING OF LOOSENING OF THE KNEE WITH INCREASED INSTABILITY AND BUCKLING GOING UP AND DOWN STAIRS. ¿EXAMINATION UNDER ANESTHESIA HAD DEMONSTRATED EXCESSIVE SWELLING OF THE KNEE COMPARED TO THE OPPOSITE KNEE AS WELL AS EXCESSIVE ANTERIOR DRAWER AT MID-FLEXION AND EXCESSIVE VARUS AND VALGUS INSTABILITY IN EXTENSION.¿ ¿¿THE POLYETHYLENE LINER WAS SEPARATED FROM THE TIBIAL TRAY WITHOUT ANY ADVERSE OR TRAUMATIC EVENT. IT WAS NOTED ON THE BACK TABLE TO HAVE EXCESSIVE WEAR IN COMPARISON TO WHAT WOULD BE EXPECTED AT THIS TIME AFTER SURGERY.¿ THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM, HAVING TOLERATED THE PROCEDURE WELL WITH NO ADVERSE EVENTS WITH PLANS FOR WEIGHTBEARING AS TOLERATED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263678 LOGIC TIBIA PS MOD INSRT SZ 3 9MM SEE H10 JWH EXACTECH, INC. 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention SEE H10.