BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 20233300 · Received September 16, 2024

    Report

    Report Number
    1644408-2024-01424
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    UDI-DI
    00888912117944
    PMA / PMN Number
    K000590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SEE D2A, D3, D4, G1, H4 AND H11 COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2018-00766; 385-09-502, S805 - WEAR/EXCESSIVE WEAR, S807 - PAIN, 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

    REVISION SURGERY - DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740037 DJO SURGICAL INSERT, STD., PRIMARY, SIZE10 13MM CM JWH ENCORE MEDICAL L.P. 501B1013 00888912117944

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention