BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 4

    MDR report key: 17919868 · Received October 12, 2023

    Report

    Report Number
    1038671-2023-02513
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    March 28, 2018
    Report Date
    December 14, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001160
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF FEMORAL LOOSENING AND POLYETHYLENE WEAR AS STATED IN THE LEGAL DOCUMENTATION. THE FEMORAL LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND/OR PATIENT-RELATED CONDITIONS. THE EXTENT AND ROOT CAUSE OF THE POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D10/D11: CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 07 0020 13 020 A10007 - GPS KNEE IMPLANT KIT. 2908308 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK. 2923965 200-02-38 - THREE PEG PATELLA 38MM. 2951006 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 32338 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFTT KNEE REPLACEMENT ON (B)(4)2014. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(4) 2018. 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)(4) 2018. DIAGNOSIS: MALALIGNED LEFT KNEE WITH LOOSE COMPONENTS. PATIENT HAD GRADUAL WORSENING PAIN. INFECTION WORKUP WAS NEGATIVE. IMAGINING STUDIES SHOWED POSSIBLE LOOSING-TIBIAL AND FEMORAL COMPONENTS. SIGNIFICANT SYNOVITIS WITH LIGHT FLAKY SYNOVIUM. FEMORAL COMPONENT WAS GROSSLY LOOSE, CAME OUT IN SURGEON¿S HAND. TIBIAL COMPONENT WAS NOT GROSSLY LOOSE BUT CAME OUT WITH NO BONE LOSS. PATELLA COMPONENT WAS WELL FIXED AND LEFT IN PLACE. DEVICES WERE TRIALED AND THEN IMPLANTED. PATIENT TOLERATED PROCEDURE WELL, NO COMPLICATIONS AND WAS TAKEN TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115227 LOGIC FEMORAL PS CEM LEFT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862001160

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention