BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT 3D METAL

    MDR report key: 25123191 · Received May 8, 2026

    Report

    Report Number
    3005180920-2026-00417
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812606
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 APRIL 2026 LOT 2243094: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2023. EXPIRATION DATE: 2027-DEC-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN AND IN THIS CASE, 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

    REVISION SURGERY DUE TO ACETABULAR CUP LOOSENING AFTER ABOUT 2 YEARS AND 10 MONTHS FROM PRIMARY. THE PATIENT STATED THAT PAIN BEGAN AFTER STANDING FROM A SEATED POSITION. THE SURGEON REVISED THE MEDACTA ACETABULAR CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE 36MM BIOLOX HEAD L TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118054 MPACT 3D METAL MPACT 3D METAL SHELL TWO HOLE Ø54MM LPH MEDACTA INTERNATIONAL SA 01.38.054DH 2243094 07630030812606

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention