BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 15MM

    MDR report key: 19827178 · Received July 25, 2024

    Report

    Report Number
    1038671-2024-02522
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230515
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4206542 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4. 5224363 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 5200424 200-02-38 - THREE PEG PATELLA 38MM. 4735135 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM. 5367415 204-70-00 - TIBIAL STEM EXT. SCREW.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO PROSTHESIS WEAR DURING 6 YEARS OF IMPLANTATION. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, MALALIGNMENT BETWEEN IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. 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 A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN MAY 2018, UNDERWENT A REVISION PROCEDURE IN JULY 2024, APPROXIMATELY 5 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE REPRESENTATIVE INDICATED THE PATIENT WAS REVISED DUE TO GENERAL POLY WEAR LIKELY DUE TO THE RECALL. THE TIBIAL COMPONENT AND NEW POLY WERE IMPLANTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS AS THEY WERE COLLECTED BY THE FACILITY AS A SPECIMEN. AN IMAGE OF THE POLY LINER WAS PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408109 LOGIC TIB INSERT IMPL CRC, SZ 4, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862230515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.