BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 3F / 3T

    MDR report key: 21263476 · Received January 29, 2025

    Report

    Report Number
    1038671-2025-00520
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    July 5, 2017
    Report Date
    January 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003966
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2022-01555 D10 CONCOMITANTS: 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3 2766483 02-012-42-3008 - LOGIC PTS, SIZE 3, 8MM 1918766, 2706824, 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T 2819503 200-02-35 - THREE PEG PATELLA 35MM 2700643 A10007 - GPS KNEE IMPLANT KIT 05 0310 13 020 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2022-01555 THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF INFECTION AND PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE 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 VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT TKA ON 16 DEC 2013 DUE TO SEVERE OSTEOARTHRITIS, RHEUMATOID ARTHRITIS. THEY SUBSEQUENTLY UNDERWENT LEFT TKA REVISION SURGERY ON 05 JUL 2017, APPROXIMATELY 3 YEARS 7 MONTHS AFTER THEIR INITIAL IMPLANTATION. IN THE YEARS FOLLOWING THE SURGERIES, THE PATIENT EXPERIENCED PAIN, SWELLING, INSTABILITY, AND BONE LOSS ON BOTH KNEES CAUSED BY EARLY AND ACCELERATED POLYETHYLENE WEAR AND/OR COMPONENT LOOSENING. ULTIMATELY, ON JULY 5, 2017, PLAINTIFF UNDERWENT AN EXTENSIVE REVISION SURGERY ON HER LEFT KNEE. 05 JUL 2017 OP REPORT: ONE-STAGE REVISION INFECTED LEFT TOTAL KNEE WITH REMOVAL OF ALL INFECTED COMPONENTS, RADICAL DEBRIDEMENT SYNOVECTOMY, AND PLACEMENT OF IN-GROWTH KNEE CONSTRUCT. REPORT STATES THAT THERE WAS YELLOW APPEARING PURULENT MATERIAL IN THE JOINT AND THERE WERE ALSO SIGNS OF METAL-WEAR DEBRIS WITH DARK-STAINED SYNOVIAL TISSUE, AS WELL AS EVIDENCE OF MICROMOTION BETWEEN THE METAL AUGMENT AND THE TIBIAL TRAY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. 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
    1996078 LGC TIBIAL FIT TRAY CEM SZ 3F / 3T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862003966

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R