BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER

    MDR report key: 9150833 · Received October 3, 2019

    Report

    Report Number
    3010536692-2019-01069
    Event Type
    Death
    Date Received
    October 3, 2019
    Date of Event
    March 28, 2017
    Report Date
    January 23, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    (B)(4). PREVIOUSLY REPORTED PAIN IN R HIP INVESTIGATED VIA MRI, FOUND TO HAVE TWO LESIONS AT THE R HIP JOINT.

    Description of Event or Problem · 1

    (B)(4). PREVIOUSLY REPORTED PAIN IN R HIP INVESTIGATED VIA MRI, FOUND TO HAVE TWO LESIONS AT THE R HIP JOINT. FINDINGS MOST CONSISTENT WITH PARTICLE DISEASE AS A RESULT OF PRIMARY HIP IMPLANT. PARTICIPANT WAS REVISED IN OR ON (B)(6) 2018 (OR REPORT LISTS PSEUDOTUMOR AND CORROSION AS DIAGNOSIS) ALL COMPONENTS OF IMPLANT WERE REMOVED. PARTICIPANT WAS DISCHARGED ON (B)(6) 2018. (B)(4). PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943907 LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. 71002846 068588511

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention