BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46

    MDR report key: 10223520 · Received July 2, 2020

    Report

    Report Number
    3005180920-2020-00371
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    June 2, 2020
    Report Date
    August 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D HIP MANAGER: THE ACETABULAR LINER SHOWS SIGNS OF POSSIBLE IMPINGEMENT, WHICH MIGHT BE IN LINE WITH THE CUP MOBILIZATION THAT CAUSED THE REVISION. ACETABULAR SHELL WITH RESIDUAL HA AND BONE FORMATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 1901410: 180 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2019. EXPIRATION DATE: 2024-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 156 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ACETABULAR COMPONENT REVISION SURGERY (CUP, HEAD AND LINER) PERFORMED 5 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS SUBOPTIMAL CUP POSITION SUGGESTING IMPLANT MOBILIZATION. SIGNS OF STEM-CUP IMPINGEMENT ARE VISIBLE ON THE EXPLANTED COMPONENT. NO IMMEDIATE POSTOPERATIVE X-RAY IS AVAILABLE.ON THE BASIS OF INFORMATION RECEIVED, IT IS NOT POSSIBLE TO DETERMINE IF THIS OCCURRED BEFORE OR AFTER CUP MOBILIZATION. THE REASON OF THIS EVENT CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: SIGNS OF OSTEOINTEGRATION ON THE OUTER SHELL AND SCRATCHES DUE TO REMOVAL PROCESS. IMPINGEMENT AREA ON CERAMIC LINER. IT IS NOT POSSIBLE TO HIGHLIGHT AN IMPLANT RELATED FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    THE SHELL MOVED (REASON UNKNOWN ) THE SURGEON DECIDED TO CHANGE CUP, LINER AND THE HEAD 4 MONTHS AND 4 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687352 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0046 1901410 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention