BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 4, 11MM

    MDR report key: 18947836 · Received March 21, 2024

    Report

    Report Number
    1038671-2024-00607
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    April 22, 2016
    Report Date
    September 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266118
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR PROSTHESIS WEAR CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY AS REPORTED OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR AND INSTABILITY CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AS THE DEVICES REMAIN IMPLANTED AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    D1: CORRECTED. D4: CORRECTED. D10: CONCOMITANT DEVICES: 02-010-06-0340 - TRU CC FEMORAL SIZE 4 RIGHT. 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. 02-012-42-4008 - LOGIC PTS, SIZE 4, 8MM. 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 02-012-60-1480 - TRU STEM EXT 14MM X 80MM. 02-012-60-1812 - TRU STEM EXT 18MM X 120MM. 02-012-65-4011 - TRU CC TIB INSERT SIZE 4, 11MM. 200-02-38 - THREE PEG PATELLA 38MM. 204-70-00 - TIBIAL STEM EXT. SCREW. 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM. 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON (B)(6) 2016 WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755148 LOGIC CC TIB INSERT SIZE 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862266118

    Patients

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