BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID TIBIAL TRAY SZ 4F/4T

    MDR report key: 21503796 · Received March 3, 2025

    Report

    Report Number
    1038671-2025-01352
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    August 14, 2023
    Report Date
    March 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862047694
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED IN CASE (B)(4) MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND TIBIAL LOOSENING, OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT AND THE TIBIAL CONSTRUCT TO THE RESPECTIVE BONE, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. 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 AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. D10: LOGIC PTS, SIZE 4, 8MM (CAT# 02-012-42-4008 / SERIAL# (B)(6)), FLUTED STEM EXTENSION 40L X 14 MM (CAT# 204-34-04 / SERIAL# (B)(6)), TIBIAL AUGMENT BLOCK 1/2-SZ 4 5MM (CAT# 204-64-05 / SERIAL# (B)(6)), TIBIAL AUGMENT BLOCK 1/2-SZ 4 5MM (CAT# 204-64-05 / SERIAL# (B)(6)), TIBIAL STEM EXT. SCREW (CAT# 204-70-00 / SERIAL# (B)(6)).

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR KNEE. UPON EXAMINATION, POLY WEAR AND OSTEOLYSIS WAS EVIDENT. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, POSSIBLE POLY SWAP. THE PATIENT UNDERWENT A FULL KNEE REVISION TO COMPETITOR'S PRODUCTS. THE POLY SHOWED EARLY WEAR AND THE METAL IMPLANTS WERE LOOSE ON THE BONE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE. THERE WAS A GREATER THAN 45 MINUTES SURGICAL DELAY, BUT THERE WERE NO ADVERSE EVENTS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695965 TRAPEZOID TIBIAL TRAY SZ 4F/4T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862047694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization SEE H11.