BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SYSTEM

    MDR report key: 21975575 · Received May 7, 2025

    Report

    Report Number
    3005180920-2025-00351
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807572
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-04-2025 LOT 2429321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-11-2024. EXPIRATION DATE: 2029-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.1150 VERSAFITCUP METALBACK CC TRIO NO-HOLE Ø50 MM (K122911) LOT 2430697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-01-2025. EXPIRATION DATE: 2029-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER: FROM THE RECEIVED PART, NO VISIBLE OR PARTICULAR DEFECTS WERE NOTICED. IN ADDITION, A FUNCTIONAL TEST WAS DONE, IN ORDER TO EVALUATE THE LINER INSERTION. AN IMPACTION TEST WAS PERFORMED WITH AN ACETABULAR SHELL VERSAFITCUP CC TRIO SIZE 50, COMPATIBLE WITH THE LINER: THE LINER RESULTED TOTALLY INSERTED AFTER FEW STRIKES WITHOUT ANY ISSUE. FROM THIS EVALUATION WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT, SINCE THE LINER CORRECTLY INSERTED DURING THE FUNCTIONAL TEST; HOWEVER, A PROBABLE CAUSE COULD BE RELATED TO AN IMPROPER ALIGNMENT WITH THE SHELL AND/OR THE PRESENCE OF LIQUID OR TISSUE STILL INSIDE THE SHELL. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. RETURNED DEVICES WERE PERFORMED WITH POSITIVE RESULTS, FAILURE OF COUPLING INTRAOPERATIVELY COULD BE DUE TO THE PRESENCE OF LIQUID OR TISSUE INSIDE THE SHELL. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    DURING SURGERY THE SURGEON COULD NOT COUPLE THE LINER WITH THE CUP. AFTER MULTIPLE ATTEMPTS A NEW IMPLANT WAS OPENED WHICH CLIPPED SUCCESSFULLY. 30 MINUTES OF DELAY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820497 VERSAFITCUP CC TRIO ACETABULAR SYSTEM LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø32/E LZO MEDACTA INTERNATIONAL SA 01.26.3244HCT 2429321 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other