BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3.5

    MDR report key: 21528179 · Received March 5, 2025

    Report

    Report Number
    1038671-2025-01434
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    March 9, 2022
    Report Date
    March 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001153
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    " D10: 02-012-44-3511 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-01374, 1038671-2025-01423. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, INSTABILITY, AND TIBIAL LOOSENING. 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

    IT WAS REPORTED THAT APPROXIMATELY 135 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-44-3511 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM, SERIAL: (B)(6), 510K: K110547, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES: SERIAL # ITEM # AND DESCRIPTION, (B)(6), 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315372 LOGIC FEMORAL PS CEM LEFT SZ 3.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001153

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| H SEE H10