BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESAFITCUP CC TRIO ACETABULAR SHELL Ø 46

    MDR report key: 7086821 · Received December 6, 2017

    Report

    Report Number
    3005180920-2017-00727
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 17 NOVEMBER 2017. PARTIAL HIP REVISION SURGERY (CUP, HEAD AND LINER) OCCURRED 4 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR-OLD WOMAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS A MOBILIZED CUP AND A FRACTURED ACETABULAR WALL. THE IMMEDIATE POST-SURGICAL POSITION OF THE CUP CANNOT BE ASSESSED AS NO X-RAY IS AVAILABLE. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 20 NOVEMBER 2017. LOT 143426: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JULY 2014. EXPIRATION DATE: 2019-06-30. 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.

    Description of Event or Problem · 1

    PATIENT RETURNED TO SURGEON FOR A CHECKED UP AND COMPLAINED OF PAIN. X-RAY REVEALED A ACETABULUM FRACTURE. SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867593 VESAFITCUP CC TRIO ACETABULAR SHELL Ø 46 CEMENTLESS ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 143426 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention