BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23836935 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01249
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731072
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-DEC-2025. LINER: MPACT 01.32.3648HC10A FACE CHANG 10° PE HC LINER D 36/F (K183582) LOT 2401183: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024 EXPIRATION DATE: 2029-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT THA WITH COMPETITOR PRODUCTS. ON (B)(6) 2025 THE PATIENT UNDERWENT REVISION DUE TO PAIN. THE SURGEON REVISED THE COMPETITOR SHELL TO MEDACTA MPACT 3D MH SHELL AND THE COMPETITOR LINER TO A MEDACTA FACE CHANGING LINER. THE COMPETITOR HEAD WAS REVISED TO A COMPETITOR HEAD. IMMEDIATE POSTOP XRAYS SHOWED DISLOCATION OF THE HEAD FROM THE LINER. THE PATIENT WAS REVISED AGAIN ON THE SAME DAY. THE SURGEON UPSIZED THE MEDACTA LINER AND REVISED THE COMPETITOR HEAD WITH A COMPETITOR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274087 MPACT ACETABULAR SYSTEM FACE CHANG 10° PE HC LINER Ø36/F LPH MEDACTA INTERNATIONAL SA 01.32.3648HC10A 2401183 07630040731072

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention