BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC RBK INSERT SZ 3.5, 9MM

    MDR report key: 15029876 · Received July 15, 2022

    Report

    Report Number
    1038671-2022-00800
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 24, 2022
    Report Date
    August 17, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 02-010-01-0235, 5402299: LOGIC FEMORAL PS CEM LEFT SZ 3.5, 02-012-43-3535, 5405726: LOGIC TIBIA RBKTRAY CEM SZ 3.5F/ 3.5T, 200-02-38, 5267286: THREE PEG PATELLA 38MM, 201-78-15, 5294247: HOLDING PIN MINI SHARP POINT 4 PK.

    Additional Manufacturer Narrative · 0

    (H3) 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 SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO INFECTION. KNEE IMPLANTS WERE REMOVED AND SPACER WAS PUT IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, DISPOSED OF BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722446 LOGIC RBK INSERT SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

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