BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 50

    MDR report key: 5709235 · Received June 9, 2016

    Report

    Report Number
    3005180920-2016-00269
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 9, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 06 JUNE 2016. LOT 104050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MARCH 2011. EXPIRATION DATE: 2016-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DOUBLE MOBILITY LINER Ø 50/28, CODE 01.26.2850M, LOT. 104181 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2011. EXPIRATION DATE: 2015-12-31. 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. ON 06 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE CUP AND LINER. THE SURGERY WAS COMPLETE SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368081 VERSAFITCUP ACETABULAR SHELL Ø 50 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 104050

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention