BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T

    MDR report key: 16490077 · Received March 6, 2023

    Report

    Report Number
    1038671-2023-00362
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 15, 2023
    Report Date
    December 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003201
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: LOGIC FEMORAL PS CEM LEFT SZ 3.5 (CAT# 02-010-01-0235 / SERIAL# (B)(4)); THREE PEG PATELLA 38MM (CAT# 200-02-38 / SERIAL# (B)(4)); LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T (CAT# 02-012-41-3535 / SERIAL# (B)(4); 3" TROCAR, MOD. HEX 2PK (CAT# 201-78-81 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY TWELVE YEARS POST INITIAL BILATERAL TKA, PATIENT LEFT KNEE WAS REVISED DUE TO PAIN. COMPONENTS WERE WELL FIXED. THE INSERT WAS FOUND TO HAVE AN UNUSUALLY METAL PIECE IMBEDDED INTO THE TOP LAYER. IT APPEARED THAT THE METAL CAPS ON THE TIBIAL BASEPLATE THAT COVER THE HOLE FOR POSSIBLE AUGMENTS WERE POTENTIALLY NEVER CAPTURED UNDER THE INSERT DURING THE INITIAL PROCEDURE. PATIENT CHOSE A DIFFERENT COMPANY FOR THE REVISION WITH SURGEON DISCUSSION. EXPLANTS NOT AVAILABLE. PATIENT LEFT IN STABLE CONDITION. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707846 LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM UNK 10885862003201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 11-4132 STRYKER SYS 6 90X13/21X1.19.| ACCELERATE CONC. SYS REP BY 620-12-02.| PLATELET RICH PLASMA KIT WITH SPRAY TIPS.