BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 19424046 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01580
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 8, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    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 POLYETHYLENE WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4256432 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5 , 5051429 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T , 5192193 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK , 5259763 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 5259781 521-78-23 - THREADED PIN SIZE 2.3 COLLARED , 5259806 521-78-23 - THREADED PIN SIZE 2.3 COLLARED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 4 YEARS 5 MONTHS POST OP. REVISION DUE TO POLY WEAR. PATIENT REVISED TO EXACTECH DEVICES: LINER WAS EXCHANGED AND PATELLA WAS RESURFACED. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423336 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 11MM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention