BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48

    MDR report key: 6215347 · Received December 30, 2016

    Report

    Report Number
    3005180920-2016-00694
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CT SCANS WERE TAKEN AND THE SURGEON SUSPECTED THAT THE CUP HAD MOVED. THE SURGEON PERFORMED THE REVISION VIA AN ANTERIOR APPROACH. WHEN HE EXAMINED THE CUP INTRAOPERATIVELY, IT WAS MOBILE. HE REMOVED THE CUP, REAMED ONE SIZE BIGGER AND IMPLANTED A 50MM CUP WITH 2 SCREWS. X-RAYS CARRIED OUT INTRAOPERATIVELY SHOWED GOOD PLACEMENT AND THE SURGEON WAS HAPPY WITH THE FIXATION. BATCH REVIEW PERFORMED ON 27 DECEMBER 2016. LOT 162918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-07-07. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A DISLOCATED HIP. WHEN THE SURGEON EXAMINED THE PATIENT, HE ESTABLISHED THAT SHE HAD DISLOCATED ANTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865387 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 162918

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention