BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM

    MDR report key: 20134075 · Received September 4, 2024

    Report

    Report Number
    1038671-2024-03254
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 20, 2024
    Report Date
    July 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001863
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: LOGIC FEMORAL PS CEM LEFT SZ 3.5 02-010-01-0235 - 4675475 LGC TIBIAL FIT TRAY CEM SZ 3.5F/3.5T 02-012-45-3535 - 4596651 THREE PEG PATELLA 32MM 200-02-32 - 4779537.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE HIGH CONTRACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL WITH THE INSERT BEING PACKAGED FOR OVER FIVE YEARS PRIOR TO IMPLANTATION, OR ANY COMBINATION OF THESE POSSIBILITIES. AS THE SUSPECT DEVICE WAS NOT PROVIDED, NONE OF THESE POTENTIAL CAUSES OR THEIR CONTRIBUTION TO THE SEQUENCE OF EVENTS CAN BE CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO ABNORMAL WEAR OF THE POLY. INITIAL IMPLANT DATE UNKNOWN. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883224 LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001863

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H11