BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005180920-2018-00829

    MDR report key: 8008973 · Received October 26, 2018

    Report

    Report Number
    3005180920-2018-00829
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 26, 2018
    PMA / PMN Number
    K132879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 OCTOBER 2018; LOT 160464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JUNE 2016. EXPIRATION DATE: 2021-06-12; 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. VISUAL INSPECTION PERFORMED ON 23RD OCTOBER 2018 BY R&D PRODUCT MANAGER: THE PROBLEM REGARDS THE COATING BUT THE IMPLANT DOES NOT SHOW ANY PARTICULAR SIGN RELATED TO THE EVENT. AS THE PACKAGING WAS NOT SHIPPED BACK TO MEDACTA, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    DURING PACKAGING OPENING THE SURGEON DETECTED COATING DEBRIS IN THE INNER PACKAGING. THE SURGEON DECIDED TO DON'T IMPLANT THE SIZE 48, TO RE-PREPARE THE ACETABULUM AND TO IMPLANT A MPACT DH SIZE 50. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other