BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM

    MDR report key: 17977172 · Received October 20, 2023

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    Report

    Report Number
    1020279-2023-02001
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    September 25, 2023
    Report Date
    July 11, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    00885556771112
    PMA / PMN Number
    K213126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: UPDATED SECTION B2, B5, D9 AND H3.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED, THE LOCKING SCREWS STARTED TO BACK OUT OF THE LOCKING HOLES ON THE EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE TO SOLVE THE ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED, THE LOCKING SCREWS STARTED TO BACK OUT OF THE LOCKING HOLES ON THE EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM. NO INTERVENTION HAS BEEN DONE YET; HOWEVER, THE SURGEON IS PLANNING A REVISION SURGERY. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038587 EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 22HM14738 00885556771112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H EVOS 4.5MM X 38MM CTX SCR S-T| EVOS 4.5MM X 42MM CTX SCR S-T| EVOS 4.5MM X 46MM CTX SCR S-T| EVOS 4.5MM X 70MM LCK SCR S-T| EVOS 4.5MM X 76MM LCK SCR S-T| EVOS 4.5MM X 76MM LCK SCR S-T| EVOS 4.5MM X 80MM LCK SCR S-T| EVOS 4.5MM X 85MM LCK SCR S-T