BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52

    MDR report key: 16643813 · Received March 30, 2023

    Report

    Report Number
    3005180920-2023-00202
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    February 16, 2022
    Report Date
    March 30, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860973
    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 30 MARCH 2023, LOT 2011703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2021. EXPIRATION DATE: 2026-04-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, DISLOCATION OF THE HEAD FROM THE CUP FOLLOWING MALPOSITIONING OF THE CUP. PATIENT REOPERATED TO MODIFY THE POSITION OF THE CUP WITHOUT DEVICE CHANGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210347 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52 HIP DOUBLE MOBILITY CUP LPH MEDACTA INTERNATIONAL SA 01.32.152MB 2011703 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention