BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM SHELL

    MDR report key: 5842598 · Received August 3, 2016

    Report

    Report Number
    3005180920-2016-00427
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    July 22, 2016
    Report Date
    August 3, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 AUGUST 2016: LOT 114581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM H CEMENTLESS STEM #1 STD, CODE 01.18.131 LOT. 114553 (K093944): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JANUARY 2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THE STEM WAS LOOSE AND THE CUP HAD MIGRATED. THE SURGEON REMOVED THE CUP, HEAD, STEM AND LINER AND REVISED WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE EXPLANTS ARE NOT AVAILABLE PER HOSPITAL POLICY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495559 VERSAFITCUP DM SHELL ACETABULAR SHELL Ø 50 MEH MEDACTA INTERNATIONAL SA 114581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention