BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    MDR report key: 20095783 · Received August 29, 2024

    Report

    Report Number
    1038671-2024-03165
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    December 29, 2023
    Report Date
    August 29, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: (B)(4) - 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5. (B)(4) - 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. (B)(4) - 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. (B)(4) - 200-02-38 - THREE PEG PATELLA 38MM. (B)(4) - 200-02-38 - THREE PEG PATELLA 38MM. 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.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(4). IT WAS REPORTED THAT APPROXIMATELY 109 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355467 LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R SEE H11