BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 6 11MM

    MDR report key: 18121058 · Received November 13, 2023

    Report

    Report Number
    1038671-2023-02756
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    July 25, 2023
    Report Date
    November 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001979
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 07012016043 A10012 - GPS IMPLANT KIT V2 4061331 02-010-01-0260 - LOGIC FEMORAL PS CEM LEFT SZ 6 4215568 200-02-41 - THREE PEG PATELLA 41MM 4300137 02-012-45-6060 - LGC TIBIAL FIT TRAY CEM SZ 6F / 6T 5X225 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    1038671-2024-04340, 1038671-2024-04338. H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED IN CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING AND/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 AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 6 YEARS AND 4 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: FAILED TOTAL LEFT KNEE THERE WAS DIFFUSE SYNOVIAL PROLIFERATION WITH TAN-COLORED AND HYPERVASCULAR STAINING TO THE SYNOVIAL LINING OF THE JOINT. THE POLYETHYLENE LINER WAS LOCKED IN THE TIBIAL TRAY, AND THERE WAS MINIMAL WEAR OF THE ARTICULAR SURFACE OF THE LINER (MEDIAL CORNER OF POSTEROLATERAL ARTICULAR ASPECT, MILD LATERAL POST EROSIVE WEAR, UNDERSURFACE INTACT) AS WELL AS GROOVING AND DELAMINATION ON THE LATERAL ASPECT OF THE PATELLAR BUTTON. THE FEMORAL COMPONENT DEBONDED FROM THE CEMENT WITH EASE. THERE WAS A LARGE UNCONTAINED DEFECT ANTERIORLY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162102 LOGIC TIBIA PS MOD INSRT SZ 6 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10