BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 13MM

    MDR report key: 17303181 · Received July 11, 2023

    Report

    Report Number
    1038671-2023-01614
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    September 26, 2022
    Report Date
    September 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001948
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 3551444 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5 2992846 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 3589502 200-02-38 - THREE PEG PATELLA 38MM. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: G3, H6, H11 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G THE REVISION WAS LIKELY THE RESULT OF PROSTHESIS WEAR OVER THE COURSE OF OVER 8 YEARS OF IMPLANTATION. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, THIRD BODY WEAR, AND HIGH CONTACT STRESS DURING KNEE FLEXION AND EXTENSION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6)2014. THE PATIENT WAS REVISED ON (B)(6)2022; REASON NOT REPORTED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233995 LOGIC TIBIA PS MOD INSRT SZ 5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-35-5013 10885862001948

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H10.