BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME

    MDR report key: 13124795 · Received December 31, 2021

    Report

    Report Number
    3010536692-2021-00617
    Event Type
    Injury
    Date Received
    December 31, 2021
    Report Date
    March 2, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    UDI-DI
    M684PHAC12541
    PMA / PMN Number
    K091423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, FOLLOWING COMPLAINTS OF PAIN AND PHYSICAL LIMITATIONS, PATIENT REPORTED FOR REVISION SURGERY OF HIS LEFT HIP PROTHESIS. PATIENT´S REVISION SURGERY WAS NECESSARY DUE TO PAIN CAUSED BY A FAILED METAL ON METAL JUNCTION CORROSION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE COURSE OF THE REVISION SURGERY THE SURGEON REMOVED PATIENTS WRIGHT MEDICAL HIP COMPONENTS, INCLUDING THE MODULAR NECK AND STEM.

    Description of Event or Problem · 0

    ALLEGEDLY, FOLLOWING COMPLAINTS OF PAIN AND PHYSICAL LIMITATIONS, PATIENT REPORTED FOR REVISION SURGERY OF HIS LEFT HIP PROTHESIS. PATIENT´S REVISION SURGERY WAS NECESSARY DUE TO PAIN CAUSED BY A FAILED METAL ON METAL JUNCTION CORROSION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE COURSE OF THE REVISION SURGERY THE SURGEON REMOVED PATIENTS WRIGHT MEDICAL HIP COMPONENTS, INCLUDING THE MODULAR NECK AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032156 PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. PHAC1254 0301086969 M684PHAC12541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention