BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 32MM

    MDR report key: 19805713 · Received July 23, 2024

    Report

    Report Number
    1038671-2024-02478
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    April 4, 2024
    Report Date
    August 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039590
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND FEMORAL LOOSENING AS REPORTED, PATIENT CONDITIONS, OR INCLUSION OF THE IMPLANTED POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 4443409 - 02-012-44-2009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM. 6309086 - 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F/2T. 6663921 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 6660789 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK. S005855 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S011086 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S041438 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. 3009220031 - A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO FEMUR LOOSENING FROM POLY, AND PATELLA WEAR. 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
    964859 THREE PEG PATELLA 32MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039590

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention SEE H11