BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 46

    MDR report key: 8141702 · Received December 7, 2018

    Report

    Report Number
    3005180920-2018-00968
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    November 7, 2018
    Report Date
    December 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808012
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 DECEMBER 2018: LOT 113444: (B)(4) PIECES RELEASED ON 30 AUGUST 2016. EXPIRATION DATE: 2021-08-16 -TOTALLY, (B)(4) PIECES PRODUCED- 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. COMMENT PROVIDED BY MEDICAL AFFAIRS DIRECTOR: ACCORDING TO THE SURGEON, THE ISSUE WAS CAUSED BY HAVING IMPLANTED A TOO BIG SIZE FOR THAT PATIENT, SO NO FURTHER ANALYSIS IS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN WAS DUE TO IRRITATION OF THE PSOAS CAUSED BY THE VERSAFIT DM CUP BEING TOO LARGE FOR THE PATIENTS ANATOMY. THE SURGEON BURRED THE EDGE OF THE DM CUP TO BETTER FIT THE PATIENTS ANATOMY AND REVISED THE LINER WITH ANOTHER COMPANY'S PRODUCT. THE SURGEON REVISED THE HEAD WITH A MEDACTA HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980805 CUP: VERSAFITCUP ACETABULAR SHELL Ø 46 CEMENTLESS HIP SHELL MEH MEDACTA INTERNATIONAL SA 113444 07630030808012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention