BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC PE LINER 50/28

    MDR report key: 4865281 · Received June 18, 2015

    Report

    Report Number
    3005180920-2015-00122
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    September 24, 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 06/18/2015: LOT 113815: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12/20/2011. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED PROBLEM. VERSAFITCUP ACETABULAR SHELL 46 CODE 01.26.46MB LOT 141659 (K083116): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06/24/2014; NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE ALREADY SOLD WITHOUT ANY SIMILAR REPORTED PROBLEM. COCR BALL HEAD 12/14 22 SIZE M CODE 01.25.123 LOT 142883 (K080885): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07/16/2014; NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED PROBLEM. AMISTEM H STEM SIZE 2 STD CODE 01.18.132 LOT 132143 (K093944): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08/02/2013. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED PROBLEM. ON 05/27/2015 IT WAS VERIFIED THAT THIS IS THE FIRST EVENT ON THE LOTS INVOLVED IN THE COMPLAINT. NO OTHER EVENTS REGISTERED ON THE SAME STERILIZATION LOTS OF THE PIECES INVOLVED IN THE CASE.

    Additional Manufacturer Narrative · 1

    ON 27 AUGUST 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 31 AUGUST 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
    395836 DOUBLE MOBILITY HC PE LINER 50/28 HC PE LINER MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1