BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 22493616 · Received July 14, 2025

    Report

    Report Number
    3005180920-2025-00650
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 21, 2025
    Report Date
    July 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JUNE 2025 LOT 2434178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/02/2025. EXPIRATION DATE: 02/02/2030. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 JUNE 2025 BALL HEADS: MECTACER 01.29.208 36MM BIOLOX DELTA HEAD S (K112115) LOT. 2436098 LOT 2436098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23/01/2025. EXPIRATION DATE: 01/01/2030. 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. 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

    AFTER 1 MONTH FROM THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826477 MPACT ACETABULAR SYSTEM FLAT PE HC LINER Ø36/E LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2434178 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention