BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP FLAT PE HC LINER Ø 32/E

    MDR report key: 5822570 · Received July 26, 2016

    Report

    Report Number
    3005180920-2016-00385
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    July 4, 2016
    Report Date
    July 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 11 JULY 2016 AND INCLUDES: THERE WAS BLOOD BETWEEN THE CUP AND LINER. BATCH REVIEWS PERFORMED ON 22 JULY 2016. LOT 156430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2016. EXPIRATION DATE: 2021-01-26. 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. VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE DIAM 50, CODE 01.26.45.1150, LOT. 160229 (K122911) LOT 160229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MAY 2016. EXPIRATION DATE: 2021-04-20. 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. ON 26 JULY 2016 THE (B)(4) PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON IMAGES OF THE ITEM RECEIVED FROM THE INITIAL REPORTER AND COMMENTED AS FOLLOWS: FROM THE RECEIVED IMAGES IT IS NOT POSSIBLE TO DETERMINE THE CAUSES OF THE EVENT. ON 26 JULY 2016 IT WAS CONFIRMED THAT THE LINER IS NOT AVAILABLE FOR INVESTIGATION. H3 NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS NOT POSSIBLE TO FIT THE LINER INTO THE CUP. ANOTHER INSERT HAS BEEN USED TO COMPLETE THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477210 VERSAFITCUP FLAT PE HC LINER Ø 32/E FLAT PE LINER LZO MEDACTA INTERNATIONAL SA 156430

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other