BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY SHELLS

    MDR report key: 20951029 · Received December 17, 2024

    Report

    Report Number
    3005180920-2024-01015
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-11-2024 LOT 083737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-02-2019. EXPIRATION DATE: 2014-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 15 YEARS AND 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP DUE TO OSTEOLYSIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455263 VERSAFITCUP DOUBLE MOBILITY SHELLS HIP CEMENTLESS DOUBLE MOBILITY CUP MEH MEDACTA INTERNATIONAL SA 01.26.54MB 083737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention