BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 11MM

    MDR report key: 18345460 · Received December 18, 2023

    Report

    Report Number
    1038671-2023-03004
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    December 1, 2023
    Report Date
    April 23, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 1832447 204-04-23 TIBIAL TRAY TRAPEZOID, CEMENTED 1733434 234-03-02 ASYMETRIC FEMORAL POSTERIOR STABILIZED, CEMENTED SZ 2 RIGHT 1888191 200-02-29 3 PEG PATELLA, CEMENTED 29MM H7: Z-0019-2022

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT OVER 13 YEARS OF IMPLANTATION. JOINT INSTABILITY MAY HAVE CONTRIBUTED TO THE WEAR OBSERVED IN THE IMAGES PROVIDED. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734 BEARINGS.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2010. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND DELAMINATION. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919819 PS TIBIAL INSERTS SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H10