BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48

    MDR report key: 12474791 · Received September 15, 2021

    Report

    Report Number
    3005180920-2021-00731
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 15, 2021
    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 23 AUGUST 2021: LOT 2007993: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2020. EXPIRATION DATE: 2025-NOV-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP DISLOCATION 4 MONTHS AFTER PRIMARY IMPLANTATION. A FEMORAL REVISION WAS PERFORMED FEW WEEKS AFTER PRIMARY SURGERY DUE TO PERIPROSTHETIC FRACTURE. HIP DISLOCATION MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY STANDARD DEVICES. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2021: STEM: AMISTEM P 01.18.401 AMISTEM-P STD STEM #1 (K173794) LOT 2005833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2020. EXPIRATION DATE: 2025-SEPT-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2021. THE PATIENT HAD FIRST REVISION SURGERY DUE TO BONE FRACTURE ON (B)(6) 2021. THE FRACTURE WAS CAUSED BY PATIENT'S FALL. ONLY AMISTEM-P STEM AND COCR HEAD WERE REVISED. M-VIZION STEM AND NEW COCR HEAD IMPLANTED. ON (B)(6) 2021 LUXATION OCCURRED DUE TO TOO MUCH ANTEVERSION OF THE CUP. CUP, HEAD, AND LINER WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372057 CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48 HIP ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0048 2007993 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention