BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM

    MDR report key: 16915721 · Received May 11, 2023

    Report

    Report Number
    1038671-2023-00972
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 3, 2023
    Report Date
    July 25, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174581
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THE REASON FOR THE WEAR COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IMAGES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 3756746 02-010-04-0350 - LOGIC CR FEMORAL POR, RIGHT, SZ 5. 3807243 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. 3967574 200-02-38 - THREE PEG PATELLA 38MM. 4200659 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 4069065 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 4069078 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 4069116 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 3947329 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 3947335 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 4050659 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 10020015031 A10012 - GPS IMPLANT KIT V2. 10021015020 A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774028 LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-48-5009 10885862174581

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention