BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3.5

    MDR report key: 22467533 · Received July 10, 2025

    Report

    Report Number
    1038671-2025-02465
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    December 8, 2022
    Report Date
    July 10, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 3940520. 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK. 4124121. 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T. 4143124. 200-02-32 - THREE PEG PATELLA 32MM. 4149968. 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE. 4136649. 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR THAT MAY HAVE BEEN SECONDARY TO GROSS INSTABILITY OF THE KNEE AND OTHER PATIENT-RELATED ISSUES. A CONTRIBUTING FACTOR TO THE EXTENT OF WEAR ON THE TIBIAL INSERT MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING BAG FOR FIVE YEARS. PROSTHESIS WEAR MAY HAVE CONTRIBUTED TO PARTICLE-INDUCED OSTEOLYSIS. THE REPORTED FEMORAL LOOSENING DUE TO LOSS OF MECHANICAL FIXATION AT THE CEMENT-IMPLANT INTERFACE MAY BE THE RESULT OF THE REVISION PROCEDURE AS THE OPERATIVE REPORT STATES THAT IT APPEARED TO BE WELL-FIXED AT THE TIME OF INITIAL TESTING. 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

    AS REPORTED, APPROXIMATELY 7 YEARS POST OP THE INITIAL LEFT TKA, THIS 59 Y/O PATIENT WAS REVISED DUE TO PAIN AND WEAR. PATIENT HAD A RECALLED IMPLANT. THE MEDIAL ASPECT OF THE JOINT SPACE SEEMED SLIGHTLY THINNER THAN THE LATERAL ASPECT INDICATING WEAR. THE FEMUR DEBONDED FROM THE CEMENT MANTLE. THE POLY SHOWED SIGNS OF DEGRADATION AND WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. DEVICES ARE NOT RETURNING; THE HOSPITAL DOES NOT ALLOW FOR THE RETURN OF EXPLANTS. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THERE WERE NO BROKEN INSTRUMENTS. THIS WAS AN IMPLANT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317476 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 59 YR Female Hospitalization| R SEE H11.