BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM

    MDR report key: 14213050 · Received April 26, 2022

    Report

    Report Number
    1038671-2022-00473
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 6, 2022
    Report Date
    September 22, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144379
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: LOGIC CR FEMORAL CEM, LEFT SZ 1.5 (CAT# 02-010-03-0215 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T (CAT3 02-012-45-1515 / SERIAL# (B)(4)). THREE PEG PATELLA 29MM (CAT# 200-02-29 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3, H6 AND H9 HAVE BEEN UPDATED ACCORDINGLY. (H3) AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY SIX YEARS POST INITIAL TKA, THIS 56 Y/O FEMALE PATIENT UNDERWENT A REVISION FOR AN UNKNOW REASON. NO ADDITIONAL INFORMATION AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION 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 BY THE LEGAL TEAM, APPROXIMATELY SIX YEARS POST INITIAL TKA, THIS (B)(6) Y/O MALE PATIENT UNDERWENT A REVISION FOR AN UNKNOW REASON. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590127 LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM UNK 10885862144379

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention