BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® MODULAR FEMORAL NECK

    MDR report key: 13358105 · Received January 26, 2022

    Report

    Report Number
    3010536692-2022-00024
    Event Type
    Injury
    Date Received
    January 26, 2022
    Report Date
    April 1, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT STARTED TO EXPERIENCE PAIN IN OR AROUND HIS RIGHT HIP JOINT, ALONG WITH COBALT AND CHROMIUM LEVELS THAT WERE INCREASING OVER THE PAST FEW YEARS. CONTINUING AND INCREASING PAIN IN HIS RIGHT HIP, AND ELEVATED SERUM COBALT/CHROMIUM LEVELS REPORTED ON (B)(6) 2019. IN THE (B)(6) 2019, RIGHT HIP REVISION PROCEDURE PATIENT´S RIGHT HIP WAS REVISED, RESULTING IN REMOVAL AND REPLACEMENT OF THE PREVIOUSLY IMPLANTED CONSERVE-DYNASTY-PROFEMUR HIP SYSTEM METAL-ON-METAL BEARING SURFACE WITH A BIOMET DUAL MOBILITY ACTIVE ARTICULATION HIP SYSTEM, AND A MICROPORT ALUMINA MATRIC COMPOSITE DELTA OPTION HEAD, AND A DELTA OPTION NECK SLEEVE. AN OPERATIVE NOTE FROM THE (B)(6) 2019, REVISION PROCEDURE REFERENCES A FINDING OF STAINED SYNOVIUM AND SIGNIFICANT CORROSION ON THE MODULAR NECK. THE EXTRACTED MODULAR NECK SHOWS SIGNIFICANT CORROSION ON BOTH THE PROXIMAL AND DISTAL TRUNNIONS OF THAT DEVICE. DUE TO CONCERNS WITH A HISTORY OF THE WRIGHT MEDICAL TITANIUM PROFEMUR MODULAR NECKS CORRODING, AND FRACTURING, THE INTRA-OPERATIVE MEDICAL DECISION WAS ALSO MADE BY SURGEON TO REMOVE AND REPLACE THE TITANIUM PROFEMUR MODULAR NECK OF THAT HIP WITH A NEW, NOT YET CORRODING, TITANIUM MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745957 PROFEMUR® MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01222 117498738 M684PHA012221

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention