BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 5 11MM

    MDR report key: 17054315 · Received June 2, 2023

    Report

    Report Number
    1038671-2023-01227
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    February 8, 2023
    Report Date
    June 8, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304636
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- UPON INVESTIGATION THIS IS FOUND TO BE A DUPLICATE COMPLAINT, ALL INFORMATION WILL CONTINUE TO BE REPORTED UNDER MFR# 1038671-2023-00240.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 4824068 201-78-18 - HOLDING PIN HEADLESS NO RIBS W/30 DEG PT 4 PACK. 4828267 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T. 4922717 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. 4941895 02-020-11-0250 - TRULIANT PS CEM FEM PS CEM LEFT SZ 5. 4944201 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. 5010613 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT UNDERWENT LEFT KNEE REPLACEMENT ON (B)(6) 2017. THEY THEN HAD LEFT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 5 YEARS 5 MONTHS AFTER THEIR INITIAL PROCEDURE. THE REASON FOR REVISION HAS NOT BEEN PROVIDED. 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
    971449 TRULIANT TIB IMP PS INSERT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-022-35-5011 UNK 10885862304636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10.