BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 24558197 · Received March 10, 2026

    Report

    Report Number
    3005180920-2026-00188
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 10, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2026. LOT 2001303: 154 ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2020. EXPIRATION DATE: 2025-APR-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION 5 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 32/D LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620922 MPACT ACETABULAR SYSTEM FLAT PE HC LINER Ø32/D LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2001303 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention