BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 16714260 · Received April 11, 2023

    Report

    Report Number
    1038671-2023-00641
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    August 31, 2022
    Report Date
    October 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173485
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- B5, D7A, D8, H2, H7, & H9. H6-INVESTIGATION -THE LOGIC DEVICE WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. CORRECTION - F10- SHOULD BE BLANK.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION- APPROXIMATELY 5 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD THE RIGHT KNEE REVISED ON (B)(6) 2022 FOR INSTABILITY OF PROSTHETIC KNEE, RIGHT REVISION TOTAL KNEE ARTHROPLASTY. THERE WERE NO COMPLICATIONS PER THE REVISION OPERATIVE REPORT AND NO UNUSUAL OR NOTABLE ISSUES IN THE REPORT. THE PATIENT HAD A BULKY COMPRESSIVE DRESSING APPLIED AND WAS THEN TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 AND THEN DISCHARGED ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(6). PER A REPORT FROM THE LEGAL DEPARTMENT, THIS PATIENT HAD A RT-KNEE REPLACEMENT DONE ON (B)(6) 2016. THE PATIENT HAD THE RT-KNEE REVISED ON (B)(6) 2022 WHICH SHOWED INSTABILITY OF THE PROSTHETIC KNEE JOINT. SERIAL #: (B)(4), CATEGORY #: 02-012-44-2011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. PMA-510K: K110547. NO EBI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402305 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM UNK 10885862173485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention UNK.