BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP FLAT PE HC LINER Ø 36 / E

    MDR report key: 6523248 · Received April 26, 2017

    Report

    Report Number
    3005180920-2017-00209
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    March 27, 2016
    Report Date
    April 26, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K120531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 24 APRIL 2017. LOT 165415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 NOVEMBER 2016. EXPIRATION DATE: 2021-10-16. 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 Ø 54, CODE 01.26.45.1154, LOT. 165406 (K122911) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 DECEMBER 2016. EXPIRATION DATE: 2021-11-20. 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. NOT EXPLANTED.

    Description of Event or Problem · 1

    DURING IMPACTION OF THE LINER, IT DIDN'T SEAT CORRECTLY AND WAS SITTING SLIGHTLY ABOVE THE LEVEL OF THE SHELL. THE SURGEON REMOVED THE LINER AND REPOSITIONED IT BEFORE IMPACTING WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304761 VERSAFITCUP FLAT PE HC LINER Ø 36 / E FLAT PE LINER LZO MEDACTA INTERNATIONAL SA 165415

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Other