BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 9109178 · Received September 24, 2019

    Report

    Report Number
    3005180920-2019-00811
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    September 17, 2019
    Report Date
    September 24, 2019
    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 6 SEPTEMBER 2019. LOT 1810745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 2024-01-29. 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 · 1

    ON 28 AUGUST 2019, WE WERE INFORMED THAT A REVISION WOULD TAKE PLACE ON (B)(6) 2019, MORE THAN 2 MONTHS AFTER PRIMARY SURGERY, BECAUSE THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON DID NOT REMOVE ANY COMPONENTS FROM THE PATIENT. THE SURGEON PERFORMED AN OPEN REDUCTION EXTERNAL FIXATION OF THE LEFT FEMUR AND INSERTED A PLATE INTO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907524 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 1810745 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention