BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 11MM

    MDR report key: 14781919 · Received June 22, 2022

    Report

    Report Number
    1038671-2022-00713
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    June 2, 2022
    Report Date
    September 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304278
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 D1, D4, D10, G3, G4, G6, H2, H3, H6 AND H9 HAVE BEEN UPDATED ACCORDINGLY. SECTION D10: CONCOMITANT MEDICAL PRODUCTS: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 (CAT# 02-020-11-0330 / SERIAL# (B)(6)). TRULIANT TIB FIT TRAY CEM SZ 3F / 3T (CAT# 02-022-45-3030 / SERIAL# (B)(6)). THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(6)). (H3) AS REPORTED BY THE LEGAL BRIEF, MALE PATIENT UNDERWENT BI-LATERAL KNEE REPLACEMENT ON OR ABOUT (B)(6), 2019. THE SURGEON USED TRULLIANT TIBIAL INSERTS FOR BOTH KNEE REPLACEMENTS. THESE PRODUCTS WERE MANUFACTURED BY EXACTECH INC. AND HAVE SINCE BEEN RECALLED BY EXACTECH. FOLLOWING THE INITIAL OPERATIONS, PATIENT HAS SUFFERED INJURIES AND DAMAGES DUE TO THE DEFECTIVE PRODUCTS, INCLUDING BUT NOT LIMITED TO, ADDITIONAL SURGICAL INTERVENTIONS ON HIS RIGHT KNEE. 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; REASON NOT REPORTED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL BRIEF, MALE PATIENT UNDERWENT BI-LATERAL KNEE REPLACEMENT ON OR ABOUT (B)(6) 2019. THE SURGEON USED TRULLIANT TIBIAL INSERTS FOR BOTH KNEE REPLACEMENTS. THESE PRODUCTS WERE MANUFACTURED BY EXACTECH INC. AND HAVE SINCE BEEN RECALLED BY EXACTECH. FOLLOWING THE INITIAL OPERATIONS, PATIENT HAS SUFFERED INJURIES AND DAMAGES DUE TO THE DEFECTIVE PRODUCTS, INCLUDING BUT NOT LIMITED TO, ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454284 TRULIANT TIB IMP PS INSERT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM UNK 10885862304278

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention