BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC PE LINER 50/28

    MDR report key: 4850210 · Received June 12, 2015

    Report

    Report Number
    3005180920-2015-00121
    Event Type
    Injury
    Date Received
    June 12, 2015
    Report Date
    October 9, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06/12/2015. LOT 091555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07/29/2009. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 093039: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04/02/2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 100182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01/23/2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 06/02/2015, THE MEDICAL AFFAIRS DR MADE THE FOLLOWING COMMENT: THERE ARE NO INFO AVAILABLE TO ALLOW A CLINICAL ANALYSIS TO BE PERFORMED. NO ROOT CAUSE IS BEING IDENTIFIED AND NO DEVICE-RELATED ACTIONS CAN BE PLANNED.

    Additional Manufacturer Narrative · 1

    ON 11 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON (B)(4) 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383663 DOUBLE MOBILITY HC PE LINER 50/28 HC PE LINER MEH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1