BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE® CUP

    MDR report key: 6860158 · Received September 12, 2017

    Report

    Report Number
    3010536692-2017-01219
    Event Type
    Injury
    Date Received
    September 12, 2017
    Report Date
    August 23, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A RECENTLY REVIEW, IT WAS DETERMINED THAT A SUPPLEMENTAL REPORT STATING, THAT THIS EVENT WAS INCORRECTLY REPORTED WAS SUBMITTED. THIS SUPPLEMENTAL REPORT (3010536692-2017-01219-01) WAS SUBMITTED IN ERROR. WE APOLOGIZE FOR ANY INCONVENIENCE THAT THIS MAY HAVE CAUSED. THE INITIAL REPORT THAT WAS SUBMITTED ON 09/12/2017 IS CORRECT.

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL REPORT, IT WAS DETERMINED THAT THERE WAS NO COMPLAINT ALLEGED AGAINST THE DEVICE. PLEASE VOID THE INITIAL REPORT.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: PAIN; METALLOSIS; POPPING SENSATION AND LIMITED MOBILITY. (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639849 CONSERVE® CUP HIP COMPONENT HWT MICROPORT ORTHOPEDICS INC. 3812-4450 089860405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention