BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY SHELLS

    MDR report key: 25297697 · Received May 27, 2026

    Report

    Report Number
    3005180920-2026-00518
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 27, 2026
    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 19 MAY 2026: LOT 2510045: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2025. EXPIRATION DATE: 2030-OCT-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED FOR THE REPORTED PAIN AND CUP MIGRATION. THE PATIENT¿S NON-ADHERENCE TO THE SCHEDULED POST-OPERATIVE FOLLOW-UP MAY HAVE CONTRIBUTED TO DELAYED IDENTIFICATION AND MANAGEMENT OF THE CUP MOVEMENT; HOWEVER, THE CAUSE OF THE EVENT REMAINS UNKNOWN. THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN THAT WAS DUE TO A CUP THAT HAD MOVED AND THE CAUSE IS UNKNOWN. THE PATIENT DID NOT ADHERE TO THE FOLLOW-UP APPOINTMENT SCHEDULE AFTER PRIMARY SURGERY. THE SURGEON REVISED THE MPACT DM D 50 CUP TO A MPACT DM D 54 CUP, REVISED THE HC D 28/DME LINER TO A HC D 28/DMG LINER, AND REVISED THE 28MM BIOLOX HEAD TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289588 MPACT DOUBLE MOBILITY SHELLS MPACT DM ACETABULAR SHELL Ø50 LPH MEDACTA INTERNATIONAL SA 01.32.150MB 2510045 07630030860966

    Patients

    Seq Age Sex Outcome Treatment
    1