BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 18735780 · Received February 19, 2024

    Report

    Report Number
    1038671-2024-00260
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    January 25, 2021
    Report Date
    September 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173591
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER D10: CONCOMITANTS: (B)(4) - 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5 (B)(4) - 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T (B)(4) - 200-02-35 - THREE PEG PATELLA 35MM (B)(4) - A10012 - GPS IMPLANT KIT V2 ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    FURTHER REVIEW DETERMINED THIS CASE IS A DUPLICATE CASE AND THE EVENT HAS BEEN REPORTED UNDER MDR#1038671-2024-01487.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN JANUARY 2021, RETURNED TO THE SURGEON WITH PAIN AND SWELLING. RECENT X-RAYS REVEALED A SIGNIFICANT ASYMMETRY BETWEEN THE IMAGE TAKEN ON THE RIGHT SIDE IN 2021 AND THE ONE TAKEN ON THE LEFT SIDE LAST WEEK. CURRENTLY, THE PATIENT IS ON THE WAITING LIST FOR A REVISION AND IS HOPEFUL THAT ONLY THE INSERT WILL NEED TO BE REPLACED. THE SURGEON, FOLLOWING TWO ISSUES OF THE SAME NATURE OCCURRING IN A SHORT PERIOD, WANTS TO INVESTIGATE THE CAUSES LEADING TO THE PREMATURE WEAR OF THE POLYETHYLENE. X-RAYS WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423698 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM UNK 10885862173591

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H10