BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23694044 · Received December 2, 2025

    Report

    Report Number
    3005180920-2025-01180
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 NOVEMBER 2025: LOT 160907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2016. EXPIRATION DATE: 2021-MAR-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LOT 121744: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2012. EXPIRATION DATE: 2017-MAY-31. 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. LOT 141168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2014. EXPIRATION DATE: 2019-MAR-31. 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 CAME IN REPORTING INSTABILITY AND STEM SUBSIDENCE. IT HAS BEEN REPORTED THAT THE PATIENT DISLOCATED 2 TIMES, BUT IT IS NOT CONFIRMED AND NO ADDITIONAL INFO ARE AVAILABLE. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958400 MPACT ACETABULAR SYSTEM FLAT PE HC LINER Ø36/E LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 160907 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention