BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 11MM

    MDR report key: 17602217 · Received August 23, 2023

    Report

    Report Number
    1038671-2023-02021
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    February 13, 2023
    Report Date
    September 19, 2023
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION THIS HAS BEEN DISCOVERED TO BE A DUPLICATE CASE, ALL NEW/ADDITIONAL INFORMATION WILL BE APPROPRIATELY PROCESSED AND REPORTED UNDER MFR# 1038671-2023-00399.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5, 2743835. 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5, 2997490. 02-012-35-5011 - LOGIC TIBIA PS MOD INSRT SZ 5 11MM, 2939289. 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, 2196984. 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, 2278193. 200-02-41 - THREE PEG PATELLA 41MM 2977798, 200-02-41 - THREE PEG PATELLA 41MM 3002224.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 8 YEARS 10 MONTHS POST PRIMARY PROCEDURE. POSTOPERATIVE DIAGNOSIS WAS FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR AND ASEPTIC FEMORAL LOOSENING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525529 LOGIC TIBIA PS MOD INSRT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNK 10885862001931

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10.