BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52

    MDR report key: 16963026 · Received May 19, 2023

    Report

    Report Number
    3005180920-2023-00360
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 21, 2023
    Report Date
    May 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 APRIL 2023: LOT 113307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2011. EXPIRATION DATE: 2016-OCT-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ANALYSIS PERFORMED BY R&D MANAGER: PRELIMINARY INVESTIGATION PERFORMED ON (B)(6) 2023. FROM THE RECEIVED IMAGES, THE SHELL APPEAR WITH THE HA COATING TOTALLY ABSORBED, WHICH IS ABSOLUTELY COMMON FOR A CUP AFTER MORE THAN 10 YEARS; THIS INDICATION SHOULD SUGGEST A CORRECT FIXATION OF THE SHELL IN THE HUMAN BODY. FROM THE RECEIVED IMAGES IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT, IF CAUSED BY IMPINGMENT BETWEEN LINER AND NECK/HEAD OR OTHER CAUSES. A FURTHER MORE DETAILED ANALYSIS CAN BE PERFORMED WITH VISUAL INSPECTION. OTHER DEVICE INVOLVED: LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE LINER Ø 32 / E (K103352) LOT 113342: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2011. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 11 YEARS 2 MONTHS, REVISION SURGERY PERFORMED. THE PATIENT HAD OSTEOLYSIS AND THE CUP HAD LOOSENED AND MOVED. THERE WAS A SIGN OF THE HEAD IN THE POLY LINER, LIKE DEFORMATION/WEAR OF THE LINER PERFORMED BY THE CONTACT WITH THE METAL HEAD. THE SURGEON REVISED SUCCESSFULLY CUP, LINER AND HEAD. STEM WAS ALSO REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853551 CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52 HIP ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0052 113307 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention