BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 24588561 · Received March 13, 2026

    Report

    Report Number
    3005180920-2026-00215
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 13, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 FEB 2026. CUP: MPACT 01.32.152DH ACETABULAR SHELL D 52 TWO-HOLES (K132879) LOT. 2348598: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2024. EXPIRATION DATE: 2029-MAY-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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. 2401987: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2024. EXPIRATION DATE: 2029-FEB-24. 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:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT1 YEAR 5 MONTHS FROM PRIMARY, THEPATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. ALL IMPLANTS WERE REMOVED, AND COMPETITOR`S DEVICES IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649652 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø52 TWO-HOLES LPH MEDACTA INTERNATIONAL SA 01.32.152DH 2348598 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention