BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4

    MDR report key: 21538214 · Received March 6, 2025

    Report

    Report Number
    1038671-2025-01458
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    January 25, 2024
    Report Date
    March 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314567
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. D10 CONCOMITANT DEVICES: (B)(6), 02-012-44-4013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM. (B)(6), 201-78-12 - HOLDING PIN LG HEAD SHARP POINT MED 2PK. (B)(6), 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T. (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486396 TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 10885862314567

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| H SEE H11