BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE MEDICAL LP

    MDR report key: 23735262 · Received December 5, 2025

    Report

    Report Number
    1644408-2025-01849
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 11, 2025
    Report Date
    February 13, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    UDI-DI
    00888912167512
    PMA / PMN Number
    K143242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D4 EXPIRATION DATE, H4, H6, H10 AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2023-00349; 342-10-706, S800 - REVISION SURGERY, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    DR DID A RT. TKR ON THIS PATIENT ON THE PATIENT DEVELOPED STIFFNESS AND DECREASED RANGE OF MOTION OVER TIME. DR DID A REVISION AND REMOVED THE 4/14MM INSERT AND IMPLANTED A 4/10MM INSERT. THIS IMPROVED THE RANGE OF MOTION. FEMALE 74.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321398 ENCORE MEDICAL LP EMPOWR 3D KNEETM INS, 4R 14MM, VE JWH ENCORE MEDICAL L.P. 342-14-704 138T1055A 00888912167512

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention