BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 15409950 · Received September 13, 2022

    Report

    Report Number
    1038671-2022-01097
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 24, 2022
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 5361391, 02-010-03-0225 - LOGIC CR FEMORAL CEM, LEFT SZ 2.5; 4888642, 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T; 5170248, 200-02-29 - THREE PEG PATELLA 29MM; 5148047, 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 5427510, 201-78-81 - 3" TROCAR, MOD. HEX 2PK.

    Additional Manufacturer Narrative · 0

    SECTION H10: (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 PLANNED REVISION CANNOT BE CONCLUSIVELY DETERMINED; INSUFFICIENT INFORMATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED VIA LEGAL, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS 69 Y/O FEMALE PATIENT WAS SCHEDULED TO UNDER GO A REVISION OF A TOTAL KNEE ARTHROPLASTY ON (B)(6), 2022. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS 69 Y/O FEMALE PATIENT WAS REVISED DUE IS SCHEDULED TO UNDER GO A REVISION OF A TOTAL KNEE ARTHROPLASTY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS 69 Y/O FEMALE PATIENT WAS SCHEDULED TO UNDER GO A REVISION OF A TOTAL KNEE ARTHROPLASTY ON (B)(6), 2022. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391522 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-47-2509 UNK 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention SEE H10