BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS SLOPE+ SZ 3.5 9 MM

    MDR report key: 17316772 · Received July 13, 2023

    Report

    Report Number
    1038671-2023-01641
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 14, 2023
    Report Date
    January 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306852
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5 (CAT# 02-020-13-0235 / SERIAL# (B)(6)) TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T (CAT# 02-022-45-3535 / SERIAL# (B)(6)) THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(6)) ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL TKA, THE 50 Y/O FEMALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. PATIENT HAD A RECALL DEVICE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209612 TRULIANT TIB IMP CR INS SLOPE+ SZ 3.5 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP CR INS SLOPE+ SZ 3.5 9 MM UNK 10885862306852

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention