BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 50

    MDR report key: 13076749 · Received December 23, 2021

    Report

    Report Number
    3005180920-2021-01009
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 23, 2021
    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 02 DECEMBER 2021: LOT 123980: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JAN-2013. EXPIRATION DATE: 2017-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 01-JAN-2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR 8.5 YEARS AFTER PRIMARY CEMENTLESS DM THA THE PATIENT FEELS GROIN PAIN AND THE SURGEON DECIDES TO REMOVE THE CUP. THE STEM IS FOUND WELL FIXED AND IN GOOD BONE. THE CUP POSITION LOOKS SLIGHTLY PROTRUDING LATERALLY, PERHAPS BECAUSE A LARGE DIAMETER CUP WAS USED, AND THIS MIGHT BE THE SOURCE OF THE PAIN, BUT OF COURSE OTHER FACTORS MAY HAVE DETERMINED THE ADVERSE REACTION. AS THERE IS NO RADIOGRAPHIC HISTORY, IT IS ALSO POSSIBLE THAT THE CUP MIGRATED FROM ITS ORIGINAL POSITION: ACCORDING TO REPORT, THE CUP WAS NOT REALLY WELL INTEGRATED. THE ROOT CAUSE FOR THIS ADVERSE EVENT CANNOT BE DETERMINED WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 0

    REVISION SURGERY AT 8 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY DUE TO GROIN PAIN. DURING THE REVISION IT WAS RECOGNIZED THAT THE SHELL WAS LOOSE. THE SURGEON REVISED SUCCESSFULLY THE SHELL, LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971542 CUP: VERSAFITCUP ACETABULAR SHELL Ø 50 CEMENTLESS ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 01.26.50MB 123980 07630030808067

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention