BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM

    MDR report key: 18922459 · Received March 18, 2024

    Report

    Report Number
    1038671-2024-00537
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    July 10, 2023
    Report Date
    August 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001856
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 5615468, 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5; 4800290, 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T; 5614979, 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. THESE DEVICES ARE USED FOR TREATMENT AND NOT DIAGNOSIS. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - G1: REPORTING CONTACT. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF POLYETHYLENE WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RADIOGRAPHS, PHOTOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED. H6: INVESTIGATION CODING.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 3 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018017 LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention