BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 19757651 · Received July 16, 2024

    Report

    Report Number
    1644408-2024-01107
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 16, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00190446257578
    PMA / PMN Number
    K172351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2022-01740; 509-02-432, S803 - DISLOCATION, 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

    RIVISION SURGERY - DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715277 DJO SURGICAL AR, SMALL SOCKET INSERT, 32MM NEUTRAL +4 EPLUS KWS ENCORE MEDICAL L.P. 953W1033 00190446257578

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention