BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 13 MM

    MDR report key: 16986118 · Received May 23, 2023

    Report

    Report Number
    1038671-2023-01084
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    March 1, 2021
    Report Date
    June 19, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307200
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- A2, A3, & B7 H6. INVESTIGATION RESULTS - THE TRULIANT INSERT WITH SERIAL NUMBER M008382 IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 6118405 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5. 6433063 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T. 6187639 200-02-29 - THREE PEG PATELLA 29MM.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT IN (B)(6) 2020. APPROXIMATELY 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION IN (B)(6) 2021 AFTER FLUID COLLECTION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410256 TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 13 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 13 MM UNK 10885862307200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SEE H10