BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 5

    MDR report key: 18654648 · Received February 6, 2024

    Report

    Report Number
    1038671-2024-00167
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 9, 2024
    Report Date
    March 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001269
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 2937068 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T . 3840208 200-02-38 - THREE PEG PATELLA 38MM . 2841608 02-012-35-5011 - LOGIC TIBIA PS MOD INSRT SZ 5 11MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO THE REPORTED PAIN, AND POSSIBLY FEMORAL LOOSENING. PROSTHESIS WEAR IS A POTENTIAL CONTRIBUTING FACTOR BUT LIKELY AN INCIDENTAL FINDING. FAILURE OF THE CEMENT USED TO SECURE THE IMPLANTS TO THE RESPECTIVE BONE, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE MALALIGNMENT BETWEEN IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PAIN, PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. 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 A 70 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 9 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THE SUBMITTED REPORT INDICATED THE PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. THE RECALLED POLY AND PATELLA COMPONENT WERE REPLACED. X-RAY IMAGES WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURN FOR ANALYSIS ANTICIPATED. DUE TO RECALL HOSPITAL WILL NOT RELEASE. IMAGES OF THE DEVICES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087594 LOGIC FEMORAL PS CEM RIGHT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 5 UNK 10885862001269

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H10