BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 4

    MDR report key: 18347331 · Received December 18, 2023

    Report

    Report Number
    1038671-2023-03013
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    August 21, 2023
    Report Date
    June 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001252
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF PROSTHESIS WEAR AND ASEPTIC LOOSENING BETWEEN THE FEMORAL COMPONENT AND THE BONE. THE LOOSENING MAY HAVE LED TO AN INCREASE IN CEMENT AND BONE PARTICLES IN THE JOINT SPACE AND RESULTED IN PROSTHESIS WEAR OR PROSTHESIS WEAR MAY HAVE CONTRIBUTED TO PARTICLE-INDUCED OSTEOLYSIS. HOWEVER, THE CONTRIBUTIONS OF PATIENT CONDITIONS, LOOSENING AND PROSTHESIS WEAR TO THE SEQUENCE OF EVENTS CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS AND PHOTOGRAPHS WERE NOT PROVIDED. 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. THE MOST COMMON 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. ALSO, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT OF "OSTEOLYSIS" IS ASSOCIATED WITH DESTRUCTION OR DISAPPEARANCE OF BONE TISSUE LIKELY RELATED TO WEAKENED INTEGRATION OF AN IMPLANT AT THE BONE-IMPLANT INTERFACE. FURTHERMORE, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT OF "PROSTHESIS WEAR" IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTANCE OR SUBSTANCES.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 6307070, 02-012-45-4030 - BANDEJA TIBIAL LOGIC FIT 4F/3T. 2910997, 02-012-35-4011 - LOGIC TIBIA PS MOD INSRT SZ 4 11MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6: HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    AS REPORTED, ON 28-NOV-2023 THIS PATIENT WAS IMPLANTED WITH A 02-012-35-4011 LOGIC TIBIA PS MOD INSRT SZ 4 11MM, SERIAL NUMBER (B)(6) ON (B)(6) 2020. PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLYETHYLENE WEAR. PATIENT HAD A LOOSE FEMUR WITH OSTEOLYTIC CAVITIES AND POSTERIOR TIBIAL DEFECT. REVISED TO COMPETITORS DEVICE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME THE INSERT WAS MANUFACTURED ON 1/8/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887489 LOGIC FEMORAL PS CEM RIGHT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001252

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male SEE H10