BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRT REVISION HIP, LATERAL OFFSET PROXIMAL BODY, 75MM

    MDR report key: 18441363 · Received January 3, 2024

    Report

    Report Number
    1644408-2023-01931
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 4, 2023
    Report Date
    December 29, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    KWZ
    UDI-DI
    00190446153856
    PMA / PMN Number
    K161610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO PREVIOUS REPORT NUMBER 1644408-2021-00644; 495-01-085, S800 - REVISION SURGERY, 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 - REMOVED HEADBALL & PROXIMAL BODY & REPLACED WITH MEW BODY & HEADBALL AFTER WASHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614953 EXPRT REVISION HIP, LATERAL OFFSET PROXIMAL BODY, 75MM PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER KWZ ENCORE MEDICAL L.P 547U1138 00190446153856

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention 400-04-280 LOT: 881B1091| 400-05-007 LOT: 888B1089