BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY SHELLS

    MDR report key: 23616979 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01168
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860966
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 NOVEMBER 2025. CUP: MPACT 01.32.150MB MPACT DM ACETABULAR SHELL D 50 (K143453) LOT 2108086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2021. EXPIRATION DATE: 16-NOV-2026. 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

    AT ABOUT 2 YEARS 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE REPRESENTATIVE REPORTED THAT THE CUP WAS ANTEVERTED AND THAT THE PATIENT WAS EXPERIENCING IMPINGEMENT. THEY INITIALLY SUSPECTED THE ISSUE WAS DUE TO A LOOSE CUP, BUT UPON FURTHER INSPECTION THE CUP WAS FOUND TO BE WELL FIXED. IT WAS OBSERVED THAT THE ACTUAL PROBLEM WAS MALPOSITION, SPECIFICALLY EXCESSIVE ANTEVERSION. THE SURGEON REVISED MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND MEDACTA HEAD TO A NEW MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347704 MPACT DOUBLE MOBILITY SHELLS MPACT DM ACETABULAR SHELL Ø50 LPH MEDACTA INTERNATIONAL SA 01.32.150MB 2108086 07630030860966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention