BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY 5

    MDR report key: 12467146 · Received September 14, 2021

    Report

    Report Number
    3005180920-2021-00728
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860980
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 6 SEPT 2021: LOT 2009458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2021. EXPIRATION DATE: 2026-FEB-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 6 SEPT 2021: LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 (K092265) LOT 2010827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 2025-OCT-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE CUP. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SAME DAY OF THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, HEAD, LINER AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367092 CUP: MPACT DOUBLE MOBILITY 5 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.154MB 2009458 07630030860980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention