BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28

    MDR report key: 11410384 · Received March 4, 2021

    Report

    Report Number
    3005180920-2021-00171
    Event Type
    Injury
    Date Received
    March 4, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 4, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2021: LOT 1909378: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2024-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52 (K143453) LOT. 180082. BATCH REVIEW PERFORMED ON 16 FEBRUARY 2021: LOT 180082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUNE-2018. EXPIRATION DATE: 2023-06-11. 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 HAD PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. STEM AND HEAD WERE REVISED WITH COMPETITOR PRODUCTS AND MEDACTA LINER WAS REVISED WITH A MEDACTA LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER, 1 MONTH AFTER THE PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308381 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28 DOUBLE MOBILITY ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 1909378 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention