BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 15MM

    MDR report key: 17920217 · Received October 12, 2023

    Report

    Report Number
    1038671-2023-02515
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    January 16, 2019
    Report Date
    October 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001832
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR/FAILURE AND INSTABILITY COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED, RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED, AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3- 2913743, 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3- 3778843, 02-012-35-3015 - LOGIC TIBIA PS MOD INSRT SZ 3 15MM- 2841071, 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T- 2945924, 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T- 3806253, 200-03-38 - ONE PEG PATELLA 38MM- 1955072, 200-03-38 - ONE PEG PATELLA 38MM- 2644870. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019 DUE TO ACCELERATED AND PREVENTABLE WEAR. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311389 LOGIC TIBIA PS MOD INSRT SZ 3 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862001832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.