BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 25230409 · Received May 20, 2026

    Report

    Report Number
    3005180920-2026-00435
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731058
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MAY 2026 REVISED STEM IN THE 1ST REVISION SURGERY: STEM: QUADRA-P 01.12.185 QUADRA-P COLLARED LAT. SIZE 5 (K192827) LOT 2338416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 26-NOV-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. REVISED HEAD AND LINER IN THE 2ND REVISION SURGERY: BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 2521396: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-SEP-2025. EXPIRATION DATE: 19-AUG-2030. 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. LINER: MPACT 01.32.3644HC4 OFFSET 4MM PE HC LINER D 36/E (K183582) LOT 2431850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2025. EXPIRATION DATE: 05-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: DISLOCATION IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    THIS WAS THE SECOND REVISION FOR PATIENT. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2024. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2025; THE STEM WAS REVISED, BUT THE REASON IS UNKNOWN. NO OTHER INFO IS AVAILABLE REGARDING THIS REVISION SURGERY. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISLOCATION OF THE HEAD FROM THE LINER. ALL COMPONENTS REVISED WITH DOUBLE MOBILITY COMPETITOR`S COMPONENT. THE REASON FOR REVISION OF THE FEMORAL STEM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279608 MPACT ACETABULAR SYSTEM OFFSET 4MM PE HC LINER Ø36/E LPH MEDACTA INTERNATIONAL SA 01.32.3644HC4 2431850 07630040731058

    Patients

    Seq Age Sex Outcome Treatment
    1