BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS SPIKED CUP

    MDR report key: 5417276 · Received February 8, 2016

    Report

    Report Number
    3010536692-2016-00236
    Event Type
    Injury
    Date Received
    February 8, 2016
    Report Date
    May 26, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION WAS RECEIVED ON 05/09/2018 THAT CHANGED THE REPORTABILITY STATUS OF THIS INCIDENT. ALLEGEDLY, THE PATIENT WAS REVISED DUE TO COCR CORROSION. UPDATED INCIDENT DESCRIPTION, DEVICE AND REPORTER INFORMATION.

    Description of Event or Problem · 0

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN (RIGHT). ADDING PATIENT NAME RECEIVED FROM LITIGATION 05/09/2018. LOCATED INVOICE AND UPDATED ITEM NUMBERS. THE COMPLAINT ALLEGES THAT THE PATIENT WAS REVISED DUE TO COCR CORROSION. THIS INCIDENT WAS INITIALLY REPORTED IN 2016 BY A SALES REP AS DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2016-00235, 00237, AND 00238.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75340 CONSERVE(R) PLUS SPIKED CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 38SP-4652 1101220083

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention