BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 54

    MDR report key: 6692850 · Received July 7, 2017

    Report

    Report Number
    3005180920-2017-00359
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 7, 2017
    Report Date
    July 7, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808128
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 JULY 2017. LOT 120582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JUNE 2012. EXPIRATION DATE: 2017-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE SURGEON DETERMINED THAT THE CUP WAS MALPOSITIONED. PRIMARY X-RAYS ARE NOT AVAILABLE. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473046 VERSAFITCUP ACETABULAR SHELL Ø 54 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 120582 07630030808128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention