BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

    MDR report key: 5685307 · Received May 27, 2016

    Report

    Report Number
    3005180920-2016-00249
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 29, 2016
    Report Date
    August 4, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 28JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY REPORTED IN THE INITIAL REPORT. ON 02 AUGUST 2016 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 20 MAY 2016 CERAMTEC PROVIDED A DOCUMENT REVIEW OF THE NON-MEDACTA PRODUCT - CERAMIC LINER - INVOLVED IN THIS COMPLAINT IN WHICH NO ANOMALIES HAVE BEEN DETECTED. BATCH REVIEWS PERFORMED ON 27 MAY 2016. LOT 124699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JANUARY 2013. EXPIRATION DATE: 2017-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. QUADRA-H, CEMENTLESS, HA COATED STEM SIZE 5 STD, CODE 01.12.025, LOT. 123628 (K082792). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP FLAT PE LINER Ø 32 / F, CODE 01.26.3248STT, LOT. 125464 (K103352). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2013. EXPIRATION DATE: 2018-01-31. 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

    REVISION PLANNED DUE TO A SUSPICION OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339060 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 124699

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention