BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY(R) A-CLASS(R) POLY LINER

    MDR report key: 3980465 · Received August 5, 2014

    Report

    Report Number
    3010536692-2014-01081
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6). THIS IS THE SAME EVENT AS 3010536692-2014-01080, 01082, 01083, 01084.

    Description of Event or Problem · 1

    ALLEGEDLY THE SURGEON COULDN'T SEAT PE LINER (28MM 0 DEGREE) WITH BF SHELL 48MM. AND HE COULDN'T SEAT PE LINER (28MM 15 DEGREES) WITH BF SHELL 48MM. AND THE PATIENT FRACTURED HER PELVIS WHEN HE PERFORMED PE LINER (28MM 15 DEGREES). AND HE COULDN'T SEAT PE LINER(32MM 0 DEGREE) WITH BF SHELL 50MM BECAUSE THE PATIENT HAD FRACTURED HER PELVIS. FINALLY HE PERFORMED BY PROCOTYL C. THE PARTS ARE CONSIGNMENT PARTS. ADD'L INFO REC'D (B)(6) 2014: THE SURGERY WAS EXTENDED ABOUT 90 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456292 DYNASTY(R) A-CLASS(R) POLY LINER HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. 1540720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention