BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 17171495 · Received June 21, 2023

    Report

    Report Number
    1038671-2023-01420
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 29, 2023
    Report Date
    January 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS: LOGIC CR FEMORAL POR, RIGHT, SZ 2.5 (CAT# 02-010-04-0325 / SERIAL# (B)(6). LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T (CAT# 02-012-45-2525 / SERIAL# (B)(6). THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(6)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THE PHOTOGRAPHED TIBIAL INSERT APPEARS UNREMARKABLE FOR AN IMPLANTED DEVICE. A CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED TIBIAL INSERT IN THE PACKAGING RECALL. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF ¿PROSTHESIS WEAR¿ IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTANCE OR SUBSTANCES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE 71 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. EVERYTHING WAS REMOVED AND REVISED INTO A COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190648 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM UNK 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention