BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 3830814 · Received May 23, 2014

    Report

    Report Number
    3010536692-2014-00864
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-00865, 00867, 00868.

    Description of Event or Problem · 1

    ORIG. SURG. (B)(6) 2006. ALLEGEDLY PT. HAS PAIN. ADD'L INFO REC'D (B)(4) 2012: ON (B)(6) 2011, DR. (B)(6) REVIEWED PT'S X-RAYS AND DISCOVERED THE HIPS WERE UNCEMENTED AND THERE WAS A MECHANICAL COMPLICATION. BILATERAL HIPS. SURGERY PERFORMED BY DR. (B)(6) AT (B)(6). ADD'L INFO REC'D (B)(4) 2014: ALLEGEDLY (B)(6) FEMALE WITH GROIN PAIN FOR THE PAST 3 YRS. PATIENT REVISED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307891 CONSERVE(R) PLUS CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 016298245

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention