BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 5F / 4T

    MDR report key: 20052762 · Received August 23, 2024

    Report

    Report Number
    1038671-2024-03052
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    April 11, 2024
    Report Date
    November 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862004048
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 1740459 02-012-35-5009 - LOGIC TIBIA PS MOD INSRT SZ 5 9MM 2914040 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5 3550289 200-02-32 - THREE PEG PATELLA 32MM THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE DISREGARD INITIAL REPORT AS IT WAS DETERMINED THIS PRODUCT WAS LOGGED IN ERROR AND IS NOT REPORTABLE.

    Description of Event or Problem · 0

    LEGAL CASE ¿ UNITED STATES (MDL NO. 3044) RELATED CASE FOR REVISION OF RK DOCUMENTED ON (B)(4). IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, RECURRENT EFFUSIONS, EXTENSIVE SYNOVITIS, OSTEOLYSIS, ASEPTIC LOOSENING OF FEMUR AND TIBIA, AND GROSSLY LOOSE PATELLA; DELAMINATED POLYETHYLENE DEBRIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387839 LGC TIBIAL FIT TRAY CEM SZ 5F / 4T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862004048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11