BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23858473 · Received December 20, 2025

    Report

    Report Number
    3005180920-2025-01299
    Event Type
    Injury
    Date Received
    December 20, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 19, 2025
    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 18 DECEMBER 2025: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER D 32/D (K103721) LOT 2312745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2023. EXPIRATION DATE: 2028-JUL-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.050DH MPACT 3D METAL SHELL TWO HOLE D 50MM (K171966) LOT 2318892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2023. EXPIRATION DATE: 2028-AUG-02. 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: 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

    THE PATIENT CAME HAD HIP PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591699 MPACT ACETABULAR SYSTEM FLAT PE HC LINER Ø32/D LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2312745 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention