BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC 52/28

    MDR report key: 12098419 · Received July 1, 2021

    Report

    Report Number
    3005180920-2021-00536
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JUNE 2021: LOT 2009653: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2020. EXPIRATION DATE: 2025-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 10 JUNE 2021: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT 2010463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2021. EXPIRATION DATE: 2025-12-29. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 9 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000798 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC 52/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 2009653 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention