BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM LINER 28/52

    MDR report key: 4761992 · Received May 6, 2015

    Report

    Report Number
    3005180920-2015-00081
    Event Type
    Injury
    Date Received
    May 6, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05/06/2015: LOT 145388: (B)(4) LINERS MANUFACTURED AND RELEASED ON 10/17/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. (B)(4) (K093944) LOT 143810: (B)(4) STEMS MANUFACTURED AND RELEASED ON 08/28/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) STEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. (B)(4) (K112115) LOT 142898: (B)(4) HEADS MANUFACTURED AND RELEASED ON 07/17/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) HEADS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. (B)(4) (K083116) LOT 145338: (B)(4) CUPS MANUFACTURED AND RELEASED ON 11/11/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) CUPS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. ON 04/09/2015 IT WAS VERIFIED THAT NO INFECTION NOR SUSPECTED INFECTION ON THE SAME STERILIZATION LOTS OF THE IMPLANTS INVOLVED IN THIS EVENT. ON 04/14/2015, THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT: THE REVISION OPERATION WAS REPORTEDLY CAUSED BY INFECTION. NO REASON TO BELIEVE THAT IT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ON 07/02/2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON 07/06/2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298291 VERSAFITCUP DM LINER 28/52 PE DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1