BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM

    MDR report key: 15394986 · Received September 9, 2022

    Report

    Report Number
    1038671-2022-01085
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    November 18, 2021
    Report Date
    April 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230485
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. CONCOMITANT MEDICAL PRODUCTS: 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4, SN: (B)(4), 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM ,SZ 4F / 4T, SN: (B)(4), 200-02-35 - THREE PEG PATELLA ,35MM, SN: (B)(4).

    Additional Manufacturer Narrative · 0

    H7: Z-0021-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 APPROXIMATELY 1 YEAR 8 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360123 LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM UNK 10885862230485

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10