BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 11MM

    MDR report key: 18332852 · Received December 14, 2023

    Report

    Report Number
    1038671-2023-02988
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    December 29, 2015
    Report Date
    December 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001931
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS - FEMUR PS CEM.Nº5 IZQ. (CAT# 02-010-01-0250 / SERIAL# (B)(6)). - BANDEJA TIBIAL LOGIC FIT 5F/5T (CAT# 02-012-45-5050 / SERIAL# (B)(6)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: A REVIEW OF THE STERILE CERTIFICATE FOR THE TIBIAL INSERT WAS PERFORMED. THE LOT WAS ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO A SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. ADDITIONALLY, INFECTION IS A KNOW SURGICAL RISK.

    Description of Event or Problem · 0

    DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH (B)(6) CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS 72 Y/O MALE PATIENT WAS IMPLANTED WITH A INSERTO TIBIAL LOGIC PS 5, 11 MM (CAT# 02-012-35-5011 / SERIAL# (B)(6)) ON (B)(6) 2015. THE INSERT WAS MANUFACTURED ON 18-JUN-2012 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS 3.30 YEARS OF SHELF AGE AT THE TIME OF IMPLANT. PATIENT WAS REVISED ON (B)(6) 2015 APPROXIMATELY 0.22 YEARS POST IMPLANT. THE IMPLANT WAS REPLACED DUE TO SUSPECTED INFECTION (NOT CONFIRMED). NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303516 LOGIC TIBIA PS MOD INSRT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM UNK 10885862001931

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention