BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 2, 13MM

    MDR report key: 15780178 · Received November 11, 2022

    Report

    Report Number
    1038671-2022-01453
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    October 19, 2016
    Report Date
    May 4, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174307
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 4079906, 02-010-03-0320 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2; 4059293, 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 4060076, 200-02-35 - THREE PEG PATELLA 35MM; 3908496, 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK); UNASSIGNED, 213-49-00 - LPI COLLAR DRILL; UNASSIGNED, 201-45-00 SAW GUIDE HOLDING DRILL 1/8 X 5.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED IN MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AND/OR INSTABILITY. HOWEVER, THE PROSTHESIS WEAR AND CONTRIBUTIONS FROM INSTABILITY TO THE REVISION CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RELEVANT CLINICAL INFORMATION WAS PROVIDED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS FEMALE PATIENT'S KNEE WAS REVISED DUE TO WEAR IN 2016. SURGEON NOTED SIGNIFICANT WEAR THE PREVIOUS INSERT AND REVISED A 13+ TO A 15 INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198848 LOGIC CR TIB INSERT SLOPE+, SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-48-2013 UNK 10885862174307

    Patients

    Seq Age Sex Outcome Treatment
    1