BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM #6 STD

    MDR report key: 4504067 · Received February 9, 2015

    Report

    Report Number
    3005180920-2015-00014
    Event Type
    Injury
    Date Received
    February 9, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/06/2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT AND IN THE FIRST FOLLOW UP. ON 07/07/2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 WE RECEIVED THE CONFIRMATION THAT THE PIECES WILL NOT BE RETURNED BACK.

    Additional Manufacturer Narrative · 1

    BATCH RECORD PERFORMED ON 02/06/2015: LOT 140015: (B)(4) ITEMS PRODUCED AND RELEASED ON 03/31/2014. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. FEMORAL HEAD CODE 01.25.012 LOT 144537 (K072857): (B)(4) ITEMS PRODUCED AND RELEASED ON 09/01/2014. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. VERSAFITCUP DM LINER CODE 01.26.2856MHC LOT 132719 (K092265): (B)(4) ITEMS PRODUCED AND RELEASED ON 09/24/2013. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89828 AMISTEM H CEMENTLESS STEM #6 STD CEMENTLESS FEMORAL STEM MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1