BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

    MDR report key: 7129081 · Received December 19, 2017

    Report

    Report Number
    3005180920-2017-00755
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 17, 2017
    Report Date
    March 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803178
    PMA / PMN Number
    K170845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PACKAGING RECEIVED FOR INVESTIGATION. VISUAL INSPECTION PERFORMED ON (B)(6) 2018 BY WASHING AND PACKAGING MANAGER: THE PACKAGING IS SCRATCHED. IT WAS CONCLUDED THAT THE DAMAGE EVIDENTLY OCCURRED DUE TO FORCES EXPERIENCED DURING TRANSPORTATION. THIS WAS INDICATED TO BE CORRELATED TO THE COMBINATION OF THE PACKAGING CONFIGURATION APPLIED AND THE SHORTER STEMS LENGTH AS THEY ALLOW MORE DEGREES OF FREEDOM FOR MOVEMENT WITHIN THE PACKAGE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 DECEMBER 2017. LOT 154899: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MAR 2016. EXPIRATION DATE: 2021-02-16 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2 REFERENCE 01.13.102L (K170845) LOT 135068: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DEC 2013. EXPIRATION DATE: 2018-10-31 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.

    Description of Event or Problem · 1

    DURING SURGERY SURGEON OPENED A FIRST PACKAGING AND FOUND THE STEM NOT IN PLACE AND THE BROKEN BLISTER. THE SURGEON OPENED A SECOND PACKAGING AND HE FOUND THAT THE STEM WAS NOT IN THE CORRECT POSITION AND HE FOUND SCRATCHES ON THE BLISTER. THE SURGEON USED THE SECOND STEM AVAILABLE IN THE ROOM SINCE HE DID NOT HAVE OTHER BACK-UP. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911540 MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2 CEMENTLESS ANATOMICAL STEM LZO MEDACTA INTERNATIONAL SA 154899 07630030803178

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other