BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 15526201 · Received October 2, 2022

    Report

    Report Number
    1038671-2022-01216
    Event Type
    Injury
    Date Received
    October 2, 2022
    Date of Event
    August 1, 2022
    Report Date
    January 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4 4741529, 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 4834475, 200-02-35 - THREE PEG PATELLA 35MM 4271375, REMEDIAL ACTION INITIATED: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: 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 POLY SWAP/REVISION HAS BEEN REPORTED TO BE DUE TO THE DEVICE RECALL; NO OTHER REASON REPORTED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO THE RECALL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315988 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention SEE H10