BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 14484948 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00391
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 APRIL 2022. LOT 1910315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2020. EXPIRATION DATE: 2025-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 2111108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2021. EXPIRATION DATE: 2026-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 20 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354611 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 HIP ACETABULAR LINER PE MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 1910315 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention