BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY SHELLS

    MDR report key: 21147020 · Received January 14, 2025

    Report

    Report Number
    3005180920-2024-01141
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808173
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 DECEMBER 2024: LOT 092508: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2009.EXPIRATION DATE: 2014-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO 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

    THE PATIENT HAD PAIN DUE TO A LOOSE CUP. AT ABOUT 14 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S IMPLANTS AND REVISED THE MEDACTA HEAD WITH ANOTHER MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897985 VERSAFITCUP DOUBLE MOBILITY SHELLS ACETABULAR SHELL CEMENTLESS Ø 56 MEH MEDACTA INTERNATIONAL SA 01.26.56MB 092508 07630030808173

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention