BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46

    MDR report key: 10949659 · Received December 4, 2020

    Report

    Report Number
    3005180920-2020-00871
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    November 8, 2020
    Report Date
    December 4, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 NOVEMBER 2020: LOT 2001422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUNE-2020. EXPIRATION DATE: 2025-MAY-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE SURGEON DECIDED TO CHANGE THE ACETABULAR SHELL. IN THE RADIOGRAPHIC IMAGE THE CUP SHOWS EXCESSIVE INCLINATION (TOO HORIZONTAL). THE REASON OF THIS POSITION IS UNKNOWN. WE CANNOT TELL IF THIS WAS THE PRIMARY POSITION AND, IF SO, THE REASONS OF THIS CHOICE AS NO PREOPERATIVE OR IMMEDIATE POSTOPERATIVE X-RAY IS AVAILABLE. IT IS VERY LIKELY THAT THE CUP NEVER FOUND ITS PRIMARY STABILITY, PERHAPS BECAUSE OF INSUFFICIENT PRESS-FIT OR INSUFFICIENT BONE QUALITY/BONE PREPARATION.

    Description of Event or Problem · 1

    2 MONTHS AFTER PRIMARY SURGERY, THE PATIENT RETURNED FOR REVISION SURGERY DUE TO MALPOSITIONED CUP, DETECTED DURING ROUTINE SURGERY FOLLOW UP VISIT. AMIS REVISION APPROACH WAS UTILIZED, THE CUP WAS FOUND TO BE WELL FIXED BUT GROSSLY MALPOSITIONED. CUP HAS BEEN REVISED SUCCESSFULLY, MPACT REVISION CUP USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414853 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46 CEMENTLESS CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0046 20001422 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention