BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM

    MDR report key: 17684050 · Received September 5, 2023

    Report

    Report Number
    1038671-2023-02153
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    November 21, 2022
    Report Date
    October 28, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001849
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2579797 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 2643824 02-012-35-3509 - LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM, 2842184 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 2843046 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5, 2945721 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5, 2993769 200-02-32 - THREE PEG PATELLA 32MM, 3609655 200-02-32 - THREE PEG PATELLA 32MM, 3612440 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK, 38024 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19, AA7196 1500-S - CEMEX SYSTEM 80G, AA7229 ASA0030 - STERILE DISPOSABLE CONTAINERS, AA7857 ASA0030 - STERILE DISPOSABLE CONTAINERS. PENDING INVESTIGATION.

    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, TIBIAL LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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) 2022. PRINCIPAL DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO MECHANICAL LOOSENING. POST-OP DIAGNOSIS: SAME. SIGNIFICANT FIBRINOUS DEBRIS WAS ENCOUNTERED INTO THE JOINT WITH A TANDEM WHITISH COLOR THIS TISSUE WAS HIGHLY FRIABLE WAS FOUND THROUGHOUT THE SUPRAPATELLAR POUCH AS WELL AS IN THE GUTTERS. THIS WAS EXCISED AND THE KNEE IN ORDER TO FULLY DEBRIDED TO VISUALIZE ALL THE COMPONENTS THEN REMOVES SIMILAR DEBRIS FROM THE ANTERIOR INTERVAL AS WELL AS DID ARE NORMAL MEDIAL RELEASE. WE THEN REMOVED THE POLYETHYLENE INSERT WITH A SINGLE PRONG RETRACTOR. THE POLY WAS NOTED TO BE YELLOW WITH SIGNIFICANT PITTING AND LOSS OF THICKNESS IN THE MEDIAL LATERAL COMPARTMENT WITH CENTRAL PITTING AND ROUGHNESS NOTED ON BOTH THE MEDIAL AND LATERAL DWELL POINTS. THE FEMORAL IMPLANT WAS GROSSLY LOOSE AND WAS REMOVED WITHOUT ANY MACHINE AND. SIMILAR FIBROUS DEBRIS WAS FOUND UNDER THE FEMORAL COMPONENT AND INTO THE POSTERIOR LATERAL. THIS WAS DEBRIDED WITH SHARP DISSECTION AS WELL AS WITH THE RONGEUR BLUNTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122127 LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862001849

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H10