BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 20316364 · Received September 26, 2024

    Report

    Report Number
    1644408-2024-01484
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    UDI-DI
    00190446258025
    PMA / PMN Number
    K173723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D3, D4 EXPIRATION DATE, G1, H4, AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2019-00181; 351-03-107, S814 - STABILITY, POOR JOINT, 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

    REVISION SURGERY - DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371450 DJO SURGICAL DJO EMPOWR KNEETM, UNIVERSAL BP, NP 5R JWH ENCORE MEDICAL L.P. 307V1075 00190446258025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other