BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM ACETABULAR-PELVIS LEFT

    MDR report key: 9483182 · Received December 17, 2019

    Report

    Report Number
    3010536692-2019-01194
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    August 26, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOT COMMERCIALLY AVAILABLE BY MPO. THEREFORE THE EVENT IS NOT REPORTABLE. PLEASE VOID THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    COMPASSIONATE USE DEVICE V190124. THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAS PAIN OVER THE PUBIC SYMPHYSIS. ON REPEAT IMAGING, THE SCREW FROM THE IMPLANT INTO THE CONTRA-LATERAL SUPERIOR PUBIC RAMUS IS MIGRATING OUT. THIS MAY NEED TO BE ADDRESSED IN A REVISION. PATIENT PRESENTING WITH A HIGH GRADE FIBROSARCOMA OF THE PELVIS. THE PATIENT REQUIRES RESECTION OF THE TUMOR AND SURROUNDING BONE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278232 CUSTOM ACETABULAR-PELVIS LEFT CUSTOM PELVIS LPH MICROPORT ORTHOPEDICS INC. CP7A0948 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention