BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 23325098 · Received October 17, 2025

    Report

    Report Number
    1644408-2025-01523
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    UDI-DI
    00888912172387
    PMA / PMN Number
    K160342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-002795, 343-12-709, S808 - INFECTION, REVISION SURGERY IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820382 DJO SURGICAL EMPOWR PS KNEETM TIBIAL INSERT, SIZE 10, 13MM   JWH ENCORE MEDICAL, L.P. 289U1005 00888912172387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention 343-13-710 LOT CODE 289U1005.| 351-02-110 LOT CODE 996R1026.