BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

    MDR report key: 17276824 · Received July 7, 2023

    Report

    Report Number
    3005180920-2023-00479
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860997
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-JUN-2023 .LOT 2113102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2022. EXPIRATION DATE: 2027-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA CUP, LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015260 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56 DOUBLE MOBILITY CUP LPH MEDACTA INTERNATIONAL SA 01.32.156MB 2113102 07630030860997

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention