BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    MDR report key: 15277648 · Received August 23, 2022

    Report

    Report Number
    1038671-2022-00957
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 27, 2022
    Report Date
    March 12, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001924
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (DEVICE EVALUATED BY MFR) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 02-012-35-5009, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 20-OCT-2025, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G4) PMA/510(K)NUMBER: K033883. (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF SUSPECTED SYNOVIAL REACTION TO PROSTHESIS WEAR, AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THE RETURNED DEVICE DID NOT APPEAR TO EXHIBIT SIGNS OF SEVERE WEAR. THE CAUSE OF THE REPORTED PAIN AND SWELLING COULD NOT BE DETERMINED. (H4) DEVICE MANUFACTURE DATE: 23-OCT-2017. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: LOGIC TIBIA PS MOD INSRT SZ 5 9MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT HAD PERSISTENT PAIN AND SWELLING. INFECTION WORKUP WAS NEGATIVE. SUSPECTED SYNOVIAL REACTION TO POLY WEAR. REVISED TO AN EXACTECH PACKAGING COMPLIANT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2822277 LOGIC TIBIA PS MOD INSRT SZ 5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001924

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention