BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 1

    MDR report key: 18707247 · Received February 14, 2024

    Report

    Report Number
    1038671-2024-00221
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 4, 2024
    Report Date
    August 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001207
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN AFTER 8 YEARS OF IMPLANTATION. HOWEVER, POTENTIAL CONTRIBUTIONS FROM OSTEOLYSIS, PROSTHESIS WEAR, AND/OR PATIENT-RELATED CONDITIONS TO THE REPORTED EVENT CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT OF "LOOSENING - FEMORAL" IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE FEMORAL COMPONENT AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(4) 2024, APPROXIMATELY 8 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. THE FEMUR APPEARED GROSSLY LOOSE ON X-RAY PER THE SURGEON. THE PATIENT WAS REVISED TO A 02-010-06-0310 LOGIC CC FEMORAL SIZE 1 RIGHT A244027, 02-010-06-0511 LOGIC POST. AUG. BLOCK SIZE 1 5MM 6811390, 02-012-60-1480 LOGIC STEM EXT 14MM X 80MM 6613674, 02-012-61-2000 LOGIC OFFSET STEM EXT COUPLER 2MM A299460, 02-022-44-1009 TRULIANT TIB IMP PSC INSERT SZ 1 9MM M000273, AND A 208-05-01 CC DISTAL FEM AUGMENT SZ 1 5MM 7028916. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS AVAILABLE DUE TO THE HOSPITAL POLICY. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781177 LOGIC FEMORAL PS CEM RIGHT SZ 1 SEE H10 JWH EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 1 UNK 10885862001207

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention 02-012-35-2011 LOGIC TIBIA PS MOD INSRT SZ 2 11MM