BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 2.5

    MDR report key: 21469024 · Received February 26, 2025

    Report

    Report Number
    1038671-2025-01240
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    September 20, 2021
    Report Date
    February 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001139
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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), 02-012-35-2515 - LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM. (B)(6), 02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5. (B)(6), 200-02-32 - THREE PEG PATELLA 32MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A FEMORAL FRACTURE ADJACENT TO THE TOTAL KNEE FEMORAL IMPLANT. THE POSTERIOR STABILIZED INSERT WAS WORN MORE THAN EXPECTED AND LEFT FEMORAL COMPONENT WAS FOUND TO BE LOOSE. THE PATELLA COMPONENT WAS ALSO LOOSE. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT AND FEMORAL FRACTURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340549 LOGIC FEMORAL PS CEM LEFT SZ 2.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2.5 10885862001139

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H SEE H11.