BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM

    MDR report key: 15503203 · Received September 29, 2022

    Report

    Report Number
    1038671-2022-01200
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 9, 2022
    Report Date
    March 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174413
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 4876820, 02-010-03-0230 - LOGIC CR FEMORAL CEM, LEFT, SZ 3; 4799531, 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; 4920867, 200-05-26 - INSET PATELLA 26MM.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF HIGH IN-VIVO FORCES AND INSTABILITY OF THE KNEE THAT ALLOWED FOR EXCESSIVE POSTERIOR AND MEDIAL CONTACT LEADING TO FULL-THICKNESS WEAR OF THE POLYETHYLENE TIBIAL INSERT AND SUBSEQUENT WEAR OF THE TIBIAL TRAY. A CONTRIBUTING FACTOR TO THE WEAR SEEN ON THE RETURNED TIBIAL INSERT MAY HAVE BEEN RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS.

    Description of Event or Problem · 0

    APPROXIMATELY 5 YRS POSTOP THE INITIAL IMPLANT, THE 77 Y/O FEMALE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, STIFFNESS, AND SWELLING IN LEFT KNEE. AFTER EXAMINATION AND X-RAY OF THE LEFT TKA, THERE IS EVIDENCE OF POLY WEAR AND POOR ALIGNMENT ON THE RADIOGRAPH. THE POLY IMPLANT THAT IS CURRENTLY IN WAS SEARCHED IN THE RECALL DATABASE AND IS A PART OF THE KNEE POLY IMPLANT RECALL. THE ORIGINAL POLY IS ALSO THE SLOPE ++ STYLE. THE PATIENT WAS SCHEDULED FOR A REVISION OF LEFT TKA, A POSSIBLE POLY SWAP FOR (B)(6) 2022. THE SURGEON OPENED THE KNEE, PERFORMED A SYNOVECTOMY, EXAMINED THE IMPLANTS AND HAD QUESTIONS ON IF THE PATELLA OR ANY OF THE EXACTECH PATELLAE ARE A PART OF THE RECALL. AS THE REPRESENTATIVE, I REPLIED NO, THE KNEE, ANKLE, AD OLD HIP POLYS ARE INVOLVED IN THE RECALL. THE SURGEON EXPLAINED THAT THE PATELLA IMPLANT LOOKED POOR OR WEIRD AND ABNORMALLY WORN FOR THE LENGTH OF TIME THAT IT HAS BEEN IMPLANTED. THE SURGEON SAID HE IS NOT CONFIDENT THAT IT IS ONLY A PACKAGING ISSUE FOR THE CAUSE OF POLY FAILURES, BUT POTENTIALLY AN ISSUE WITH THE MANUFACTURING PROCESS ITSELF. THE SURGEON THEN PAID ATTENTION TO THE TIBIAL INSERT POLYETHYLENE. IT WAS REMOVED WITH A 1/4" CURVED OSTEOTOME. THE POLY PRESENTED WITH SEVERE POSTERIOR WEAR, DELAMINATION, AND PITTING THROUGHOUT THE ARTICULAR SURFACE. THERE WAS PIECES OR FRAGMENTS OF THE POLY INSERT THAT WERE FLOATING IN THE JOINT SPACE THAT WERE REMOVED. THE JOINT WAS WASHED OUT, A FURTHER SYNOVECTOMY WAS PERFORMED AND THEN THE METAL IMPLANTS WERE EXAMINED. THERE WAS EVIDENCE OF OSTEOLYSIS AND THERE WAS OBVIOUS TIBIAL BASEPLATE WEAR ACCORDING TO THE SURGEON. HE EXPLAINED THAT A POLY SWAP WOULD NOT BE IN THE PATIENT¿S BEST INTEREST DUE TO THIS. THE SURGEON DECIDED TO COVERT THE EXACTECH CR TKA TO A ZIMMER PERSONA REVISION TKA. THE EXACTECH IMPLANTS THAT WERE REMOVED WERE REQUESTED TO BE SAVED AND RETURNED TO EXACTECH FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588869 LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-49-3009 UNK 10885862174413

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention