BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM

    MDR report key: 18650046 · Received February 6, 2024

    Report

    Report Number
    1038671-2024-00154
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    August 10, 2020
    Report Date
    January 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173584
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 208-06-01 - CC DISTAL FEM AUGMENT SZ 1, 10MM; (B)(6) 208-21-15 - CC TIBIAL INSERT SZ 1, 15MM; (B)(6) 208-06-01 - CC DISTAL FEM AUGMENT SZ 1, 10MM; (B)(6) 204-41-89 - TIBIAL AUGMENT BLOCK 1/3-SZ 1 11MM LLRM; (B)(6) 204-04-21 - TRAPEZOID TIBIAL TRAY SZ 1F/1T, 2F/1T; (B)(6) 204-38-12 - STEM EXTENSION W/SLOT 120L X18 MM; (B)(6) 02-012-42-2508 - LOGIC PTS, SIZE 2.5, 8MM; (B)(6) 140-32-00 - 12/14 BIOLOX FEMORAL HD 32MM +0; (B)(6) 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5; (B)(6) 204-34-08 - FLUTED STEM EXTENSION 80L X 14 MM; (B)(6) 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE; (B)(6) 200-02-41 - THREE PEG PATELLA 41MM; (B)(6) 02-012-41-2525 - LOGIC TIBIA TRAPTRAY CEM SZ 2.5F/2.5T; (B)(6) 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3; (B)(6) 02-012-41-3030 - LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T; (B)(6) 160-33-16 - NV SPLINED HA RDD X/O SZ 16; (B)(6) 02-012-44-2509 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 9MM; (B)(6) 200-02-35 - THREE PEG PATELLA 35MM; (B)(6) 200-02-29 - THREE PEG PATELLA 29MM; (B)(6) 208-01-01 - CC FEMORAL SZ 1D, 1. PENDING INVESTIGATION E1: (B)(6).

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOSS OF RANGE OF MOTION, AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL/UPDATED INFORMATION ¿ B5, H6 MEDICAL DEVICE PROBLEM. H3. INVESTIGATION RESULTS - THE CAUSE OF THE PATIENT'S INFECTION AND POLY REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. CLINICAL INFORMATION ABOUT THE PATIENT WAS NOT AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION. CORRECTION ¿ B3, D6B.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.CORRECTED FIELDS: B1, B2, B7, G2, H6.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: CHRONIC PERIOPROSTHETIC INFECTION. FINDINGS: SINUS TRACT THROUGH THE MEDIAL FASCIA OVER THE PROXIMAL MEDIAL TIBIA, SLIMY SYNOVIUM, LOOSE FEMORAL COMPONENT, WELL FIXED TIBIAL COMPONENT, PURULENT FLUID WITHIN THE SINUS TRACT. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT AWAKE, ALERT, AND STABLE.

    Description of Event or Problem · 0

    UPDATED INFORMATION-AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 6 YEARS, 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE IRRIGATION AND DEBRIDEMENT AND POLYETHYLENE EXCHANGE ON (B)(6) 2020. THE PATIENT HAD DONE WELL UNTIL IT WAS NOTED THAT HE HAD SIGNIFICANT FLUID IN HIS KNEE. THIS FLUID WAS ASPIRATED AND WAS FOUND TO HAVE BACTERIA. HE WAS DIAGNOSED WITH ACUTE ON CHRONIC PERIPROSTHETIC LEFT KNEE INFECTION. HE WAS PLACED ON IV ANTIBIOTICS FOLLOWED BY A YEAR-LONG COURSE OF ORAL ANTIBIOTICS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. NO X-RAYS OR IMAGES OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955832 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10.