BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 12192987 · Received July 19, 2021

    Report

    Report Number
    1038671-2021-00347
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 28, 2021
    Report Date
    November 22, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    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) AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL IMPLANT, THE 83 Y/O FEMALE PATIENT EXPERIENCE KNEE PAIN, AND THE RIGHT KNEE WAS REVISED DUE TO INSTABILITY OF THE TIBIA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISPOSED BY THE HOSPITAL. UPON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED REVISION WAS LIKELY THE RESULT OF UNDERLYING PATIENT FACTORS, WHICH LED TO INSTABILITY OF THE JOINT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T (CAT# 02-012-45-4040 / SERIAL# (B)(4)), LOGIC CR FEMORAL POR, RIGHT, SZ 4 (CAT# 02-010-04-0340 / SERIAL# (B)(4)), THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL IMPLANT, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCE KNEE PAIN, AND THE RIGHT KNEE WAS REVISED DUE TO INSTABILITY OF THE TIBIA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISPOSED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084042 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM UNK 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention