BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23864303 · Received December 22, 2025

    Report

    Report Number
    3005180920-2025-01311
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731072
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DEC 2025. LINER: MPACT 01.32.3648HC10A FACE CHANG 10°; PE HC LINER D 36/F (K1835829 LOT: 2401183: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 FEBRUARY 2024. EXPIRATION DATE: 21 JAN 2029. 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. BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 D 36 SIZE XL +8 (K112115) LOT: 2311918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2023. EXPIRATION DATE: 29 MAY 2028. 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 UNDERWENT PRIMARY RIGHT HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE FEMORAL HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER (MDR: (B)(4). ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE FEMORAL HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND UPSIZED THE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257822 MPACT ACETABULAR SYSTEM FACE CHANG 10° PE HC LINER Ø36/F LPH MEDACTA INTERNATIONAL SA 01.32.3648HC10A 2401183 07630040731072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention