BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT OFFSET 4MM PE HC LINER 32/C

    MDR report key: 11106982 · Received January 4, 2021

    Report

    Report Number
    3005180920-2021-00005
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040730754
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2020: LOT 2002179: 15 ITEMS MANUFACTURED AND RELEASED ON 2-JUN-2020. EXPIRATION DATE: 2025-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 1 MONTH FROM THE PREVIOUS REVISION SURGERGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD (COMPETITOR) FROM THE LINER (MEDACTA). THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR HEAD AND THE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUS REVISION SURGERY REASON WAS STEM MOBILIZATION (THE STEM AND HEAD WERE REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9456 MPACT OFFSET 4MM PE HC LINER 32/C HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.3239HC4 2002179 07630040730754

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention