BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46

    MDR report key: 7624921 · Received June 21, 2018

    Report

    Report Number
    3005180920-2018-00440
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    May 22, 2018
    Report Date
    June 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JUNE 2018. LOT 161324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MAY 2016. EXPIRATION DATE: 2021-05-19 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AFTER PRIMARY. THE SURGEON DETERMINED THAT THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGEON USED ANOTHER COMPANY'S CUP AND LINER WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467191 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 161324 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention