BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 16109366 · Received January 5, 2023

    Report

    Report Number
    1038671-2023-00023
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 14, 2022
    Report Date
    May 28, 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

    CONCOMITANT PRODUCTS: LOGIC CR FEMORAL POR, RIGHT, SZ 2.5 (CAT# 02-010-04-0325 / SERIAL# (B)(4)). 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 REASON FOR THE REVISION MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AS REPORTED, PATIENT CONDITIONS, OR INCLUSION OF THE IMPLANTED POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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 2.5 YEARS POST INITIAL BILATERAL TKA, THE 56 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR AND INSERTS CHANGE AND PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE DEVICES WERE DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387606 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