BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY SHELLS

    MDR report key: 23510641 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01122
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 OCTOBER 2025, CUP: MPACT 01.32.148MB IMPACT DM ACETABULAR SHELL D 48(K143453) LOT 2307257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2023. EXPIRATION DATE: 03-OCT-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

    AT ABOUT1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEONREVISED THE LINER, HEAD AND UPSIZED CUP AFTER DETERMINING THAT THE CUP WASMALALIGNED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543356 MPACT DOUBLE MOBILITY SHELLS MPACT DM ACETABULAR SHELL Ø48 LPH MEDACTA INTERNATIONAL SA 01.32.148MB 2307257 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention