BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50

    MDR report key: 15690002 · Received October 28, 2022

    Report

    Report Number
    3005180920-2022-00790
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808067
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 OCTOBER 2022: LOT 2110831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2021. EXPIRATION DATE: 2026-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 2 WEEKS AFTER PRIMARY FOR CUP MOBILIZATION. THE REASON OF MOBILIZATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725007 CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50 HIP ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 01.26.50MB 2110831 07630030808067

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention