BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E

    MDR report key: 14694831 · Received June 15, 2022

    Report

    Report Number
    3005180920-2022-00470
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 15, 2022
    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 31 MAY 2022. LOT 2118276: (B)(4). EXPIRATION DATE: 2026-DEC-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 31 MAY 2022. LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352) LOT 2118277: (B)(4). EXPIRATION DATE: 2026-DEC-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). CUP: VERSAFITCUP CC TRIO (B)(4) ACETABULAR SHELL CC TRIO NO-HOLE Ø 52 (K122911) LOT 2113088: (B)(4). EXPIRATION DATE: 2026-NOV-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). VISUAL INSPECTION PERFORMED ON 15 JUNE 2022. THE RECEIVED PARTS WERE ANALYSED, FINDING NO EVIDENT PARTICULAR SIGNS. A FUNCTIONAL TEST WAS PERFORMED IN ORDER TO EVALUATE THE COPLING BETWEEN THE SHELL AND THE LINER; AFTER FEW IMPACTIONS, THE LINER WAS CORRECTLY INSERTED INTO THE SHELL. FROM THE RECEIVED PARTS AND INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; A POSSIBLE CAUSE CAN BE RELATED TO THE PRESENCE OF SOME RESIDUAL OF FLUIDS IN THE BOTTOM OF THE SHELL, PREVENTING THE TOTAL COMPLING OF THE PARTS.

    Description of Event or Problem · 0

    IT WAS NOT POSSIBLE TO INSERT THE VERSAFITCUP PE HC LINER E 32MM IN THE VERSAFITCUP 52MM. THE SURGEON TRIED 2 LINERS AND IT WAS EITHER NOT POSSIBLE. AFTERWARD, HE IMPLANTED THE 54MM VERSAFIT AND WITH THIS CUP, IT WAS POSSIBLE TO INSERT THE SAME LINER. AT LEAST 30 MINUTES OF DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910398 VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.26.3244HCT 2118276 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other