BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM

    MDR report key: 14824596 · Received June 26, 2022

    Report

    Report Number
    1038671-2022-00723
    Event Type
    Injury
    Date Received
    June 26, 2022
    Date of Event
    March 29, 2022
    Report Date
    September 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144331
    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: THREE PEG PATELLA 26MM (CAT# 200-02-26 / SERIAL# (B)(4)). LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5 (CAT# 02-010-03-0315 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T (CAT# 02-012-45-1515 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Additional Manufacturer Narrative · 0

    H3: AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019. PATIENT'S UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022 DUE TO PREMATURE FAILURE OF HIS EXACTECH OPTETRAK TOTAL KNEE DEVICE. 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; NO REASON FOR REVISION WAS GIVEN. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019. PATIENT'S UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022 DUE TO PREMATURE FAILURE OF HIS EXACTECH OPTETRAK TOTAL KNEE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267259 LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM UNK 10885862144331

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention