BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

    MDR report key: 7435646 · Received April 17, 2018

    Report

    Report Number
    3005180920-2018-00237
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    March 18, 2018
    Report Date
    April 17, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 APRIL 2018. VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 REFERENCE 01.26.2852MHC LOT 173582: (B)(4). MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 REFERENCE 01.29.202 (K112115) LOT. 172250: (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION, ABOUT 1 MONTH AND HALF FROM THE PRIMARY SURGERY. THE PATHOGEN WILL NOT BE AVAILABLE. THE SURGEON WASHED OUT THE HIP AND REVISED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280467 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 173582 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention