BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM

    MDR report key: 15331635 · Received August 31, 2022

    Report

    Report Number
    1038671-2022-00986
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 2, 2022
    Report Date
    October 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230447
    PMA / PMN Number
    K123342
    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 MEDICAL PRODUCTS: THREE PEG PATELLA 35MM 200-02-35, LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T 02-012-45-3535, LOGIC CR FEMORAL POR, LEFT, SZ 3.5 02-010-04-0235. DEVICE EVAUATED BY MFR: NO DEVICE RETURN ANTICIPATED AS THE DEVICES WERE DISPOSED OF BY THE HOSPITAL. (B)(4).

    Additional Manufacturer Narrative · 0

    H7: Z-0021-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, WEIGHT 91.15 KG, THAT HAD AN INITIAL LEFT KNEE PROCEDURE ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE DUE TO A STIFF KNEE APPROXIMATELY 1 YEAR 4 MONTHS POST THE INITIAL IMPLANT DATE. THEY WERE REVISED TO EXACTECH DEVICES. NO EXPLANT WILL BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832463 LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM UNK 10885862230447

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R SEE H10.