BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC FEMORAL SIZE 3, LEFT

    MDR report key: 12089005 · Received June 29, 2021

    Report

    Report Number
    1038671-2021-00318
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    June 10, 2021
    Report Date
    October 20, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265661
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) AS REPORTED, APPROXIMATELY 10 MONTHS POSTOP THE INITIAL IMPLANT, THIS 56 Y/O FEMALE PATIENT HAD A LTKA REVISION DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY HOSPITAL. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LOGIC STEM EXT 14MM X 40MM (CAT# 02-012-60-1440 / SERIAL# (B)(4)). TIBIAL STEM EXT. SCREW (CAT# 204-70-00 / SERIAL# (B)(4)). LGC TIBIA PS RBK INSRT SZ 3 9MM (CAT# 02-012-38-3009 / SERIAL# (B)(4)). THREADED PIN SIZE 2.3 COLLARED (CAT# 521-78-23 / SERIAL# (B)(4)). THREADED PIN SIZE 3.0 COLLARED (CAT# 521-78-32 / SERIAL# (B)(4)). LOGIC POST. AUG. BLOCK SIZE 3, 5MM (CAT# 02-010-06-0531 / SERIAL# (B)(4)). LGC TIBIA RBKTRAY CEM SZ 3F/ 2T (CAT# 02-012-43-3020). THREE PEG PATELLA 35MM (CAT# 200-02-35). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 10 MONTHS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT HAD A LTKA REVISION DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982763 LOGIC CC FEMORAL SIZE 3, LEFT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CC FEMORAL SIZE 3, LEFT UNK 10885862265661

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention