BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY SHELLS

    MDR report key: 20618352 · Received November 6, 2024

    Report

    Report Number
    3005180920-2024-00886
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808128
    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 08-OCT-2024. LOT 083737: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2009. EXPIRATION DATE: 2014-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396276 VERSAFITCUP DOUBLE MOBILITY SHELLS HIP ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 01.26.54MB 083737 07630030808128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention