BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 13MM

    MDR report key: 19057824 · Received April 8, 2024

    Report

    Report Number
    1038671-2024-00754
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    September 5, 2023
    Report Date
    November 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304292
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICES 4791349 200-02-35 - THREE PEG PATELLA 35MM 4904576 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 4913627 204-70-00 - TIBIAL STEM EXT. SCREW 4940375 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 4942386 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B2, D4, H4, G2, G3, G4, H4, H6, H11 THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO 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 IMAGES 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418425 TRULIANT TIB IMP PS INSERT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R