BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60

    MDR report key: 9191667 · Received October 15, 2019

    Report

    Report Number
    3005180920-2019-00871
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 17, 2019
    Report Date
    October 15, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861017
    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 15-OCT-2019: LOT 181132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 20/06/2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2860MHC DOUBLE MOBILITY HC LINER 28/DML (K092265) LOT. 180156 BATCH REVIEW PERFORMED ON 15-OCT-2019: LOT 180156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2018. EXPIRATION DATE: 21/03/2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 10 MONTHS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE MEDACTA VERSAFITCUP DM LINER HC 60/28 AND MEDACTA MPACT DM ACETABULAR SHELL AND INSERTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985656 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60 ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 181132 07630030861017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention