BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 11MM

    MDR report key: 18627219 · Received February 1, 2024

    Report

    Report Number
    1038671-2024-00146
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 30, 2024
    Report Date
    October 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304186
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL LEGAL COMPLAINT RECEIVED 27 DEC 2023, INFORMATION RECEIVED 30 JAN 2024 THAT PATIENT WAS REVISED ON (B)(6) 2024. D10. CONCOMITANTS: 5920152 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5. 5749079 02-022-45-2515 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 1.5T. 5757639 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.CORRECTION FIELDS: B2, G, G2, H6-CLINICAL CODE, COMPONENT CODE, INVESTIGATION CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD AN INITIAL LEFT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2019 AND THEN APPROXIMATELY 4 YEARS 7 MONTHS LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON 30 JAN 2024. THE PATIENT COMPLAINED OF PAIN. REVISION FOR LOOSE FEMUR AND RECALLED POLY. POLYETHYLENE WEAR. THE PATIENT REVISED TO EXACTECH DEVICES. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED, THE HOSPITAL WILL NOT RELEASE IT. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249249 TRULIANT TIB IMP PS INSERT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304186

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| R SEE H10.