BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 16732181 · Received April 13, 2023

    Report

    Report Number
    3005180920-2023-00269
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    April 13, 2022
    Report Date
    April 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 MARCH 2023: LOT 2102393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JULY-2021. EXPIRATION DATE: 2026-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY ABOUT 1 MONTH POST PRIMARY FOR INFECTION. THE SURGEON REVISED THE MEDACTA CUP SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979245 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 HIP DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.148MB 2102393 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention