BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM

    MDR report key: 15421956 · Received September 14, 2022

    Report

    Report Number
    1038671-2022-01115
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 15, 2022
    Report Date
    October 1, 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

    NO DEVICE RETURN ANTICIPATED DUE TO IT WAS DISPOSED OF BY THE CUSTOMER. CONCOMITANTS: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 4.5T 02-012-45-3545 SN: (B)(4), LOGIC CR FEMORAL POR, LEFT, SZ 3.5 02-010-04-0235 SN: (B)(4), THREE PEG PATELLA 38MM 200-02-38 SN: (B)(4). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. H7: Z-0021-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 62 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON 10/17/2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 9 MONTHS POST THE INITIAL PROCEDURE DUE TO INSTABILITY. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609405 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 10885862230447

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H10.