BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM

    MDR report key: 16643953 · Received March 30, 2023

    Report

    Report Number
    1038671-2023-00549
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 6, 2023
    Report Date
    February 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144423
    PMA / PMN Number
    K111400
    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

    H3: THE REVISION REPORTED WAS LIKELY THE COMBINATION OF THE SLOPE ++ TIBIAL INSERT AND THE POSITIONING OF THE FEMORAL COMPONENTS RELATIVE TO THE TIBIAL COMPONENTS WHICH ALLOWED FOR EXCESSIVE POSTERIOR CONTACT BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL INSERT, ESPECIALLY LATERALLY, AND LED TO THE OBSERVED WEAR OF THE POLYETHYLENE AND PAIN. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND A LATERAL PRE-REVISION RADIOGRAPH WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: SERIAL #: (B)(6), CATALOG #: 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5, SERIAL #: (B)(4), CATALOG #: 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T, SERIAL #: (B)(6), CATALOG #: 200-02-29 - THREE PEG PATELLA 29MM. CORRECTION/REMOVAL NUMBER: Z-0021-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2017. THE PATIENT RETURNED WITH COMPLAINTS, INCLUDING PAIN AND DISSATISFACTION. THE PATIENT UNDERWENT A POLY SWAP ON (B)(6)2023 AND WAS REVISED TO A SIZE 15MM CRC POLY, SZ 1.5. PIECES OF POLY WERE REMOVED FROM THE PATIENT'S WOUND SITE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442648 LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-49-1513 10885862144423

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention SEE H10.