BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

    MDR report key: 8821370 · Received July 24, 2019

    Report

    Report Number
    3005180920-2019-00599
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807756
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 MAY 2019: LOT 173463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SET-2017. EXPIRATION DATE: 2022-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY PERFORMED 1,5 YEARS AFTER PRIMARY HYBRID TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. POOR QUALITY OF THE IMAGE PROVIDED DOES NOT ALLOW A PROPER EVALUATION OF THE CEMENT MANTLE AND RADIOTRANSPARENT ZONES. THE REASON OF THIS EVENT CANNOT BE DETERMINED. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 22 MAY 2019: STEM: AMISTEM C 01.18.152 CEMENTED STD STEM SIZE 2 LOT. 176514 (K103189): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2017. EXPIRATION DATE: 2022-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY DUE TO RADIOLUCENCIES (STEM + ACETABULUM) AND STEM LOOSENING. THE CUP, LINER, BALL HEAD AND STEM HAVE BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615430 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 173463 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention