BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM

    MDR report key: 18957138 · Received March 22, 2024

    Report

    Report Number
    1038671-2024-00637
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    April 7, 2022
    Report Date
    May 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173614
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION RESULTS - THE REVISION REPORTED MAY HAVE BEEN 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. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RADIOGRAPHS/PHOTOGRAPHS AND OPERATIVE NOTES WERE NOT PROVIDED. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 02-012-45-3545 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 4.5T; (B)(6). 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5; (B)(6). THESE DEVICES ARE USED IN TREATMENT AND NOT IN DIAGNOSIS. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 4 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488196 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173614

    Patients

    Seq Age Sex Outcome Treatment
    1