BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

    MDR report key: 5619809 · Received April 29, 2016

    Report

    Report Number
    3005180920-2016-00194
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    March 31, 2016
    Report Date
    July 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 28 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 06 JULY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 APRIL 2016. LOT 122966: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2012. EXPIRATION DATE: 2017-08-31. 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. DEVICE NOT EXPLANTED

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO DISLOCATION OF THE HIP. THE SALES AGENT DOES NOT KNOW HOW THE DISLOCATION OCCURRED. THE SURGEON RE-POSITIONED THE CUP AND ADDED 2 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGERY PERFORMED WITH A POSTERIOR APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277138 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 122966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention