BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR NECK

    MDR report key: 21885853 · Received April 22, 2025

    Report

    Report Number
    3010536692-2025-00170
    Event Type
    Injury
    Date Received
    April 22, 2025
    Report Date
    December 4, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. THE PROVIDED LITERATURE DOCUMENT STATES THAT 83 PATIENTS WITH A COCR MODULAR NECK WERE FOUND TO HAVE ELEVATED SERUM COBALT LEVELS. FOR PATIENTS WITHOUT METAL-ON-METAL ARTICULATION, ELEVATED SERUM COBALT LEVELS WERE PAIRED WITH A PSEUDOTUMOR FOR 11 PATIENTS WHILE 38 PATIENTS WERE WITHOUT PSEUDOTUMOR. FOR THE METAL-ON-METAL ARTICULATION GROUP, 14 PATIENTS HAD ELEVATED SERUM COBALT LEVELS PAIRED WITH A PSEUDOTUMOR WHILE 20 PATIENTS WERE WITHOUT PSEUDOTUMOR. MPO DOES NOT HAVE SPECIFIC INFORMATION REGARDING PRODUCTS, MANUFACTURING LOTS, PATIENT DETAILS, OR DATES. FURTHERMORE, MPO CANNOT DETERMINE FROM THE AVAILABLE INFORMATION IF ANY OF THESE OCCURRENCES HAVE BEEN PREVIOUSLY CAPTURED AND INVESTIGATED. INVESTIGATION CONCERNING PATIENT REACTIONS TO COBALT CHROME MODULAR NECKS HAVE BEEN INVESTIGATED AND MONITORED THROUGH CORRECTIVE AND PREVENTIVE ACTION (CAPA) #282. THIS CAPA STATES, "THE POTENTIAL FOR A PATIENT REACTION WHEN IMPLANTED WITH A PROFEMUR® COCR MODULAR NECK IS A KNOWN RISK FOR THIS PRODUCT TECHNOLOGY. A COMBINATION OF PATIENT AND SURGICAL FACTORS CAN CONTRIBUTE TO AN ELEVATED RISK OF AN ADVERSE PATIENT REACTION. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PATIENT SENSITIVITY, SURGICAL TECHNIQUE, PATIENT WEIGHT AND ACTIVITY LEVEL." CONCERNING THE PATIENTS WITH METAL-ON-METAL ARTICULATION, IT CANNOT BE DETERMINED THE EXTENT THAT THE COCR MODULAR NECK COULD HAVE CONTRIBUTED TO THE ALLEGED ELEVATED ION LEVELS COMPARED TO THE BEARING COMPONENTS. DESPITE THE LARGE QUANTITY FOR COMPLAINT RESULTING IN A SPIKE IN COMPLAINTS BETWEEN INCIDENTS (B)(4), MPO HAS CONFIRMED THAT THE CURRENT OCC VALUE IS THE SAME AS THE OCC VALUE IN THE CURRENTLY APPROVED DFMEA FOR THIS PRODUCT, (B)(4). NO FURTHER CONCLUSIONS CAN BE MADE FROM THE AVAILABLE INFORMATION. BASED ON THIS INFORMATION, NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. MPO WILL CONTINUE TO MONITOR FOR THIS COMPLAINT ISSUE.

    Description of Event or Problem · 0

    ALLEGEDLY, A LITERATURE DOCUMENT WAS RECEIVED DETAILING THE FOLLOWING: ZACHARY-2021: 83 CASES OF ELEVATED SERUM COBALT LEVELS. NO REVISIONS. ZACHARY 2021- COBALT LEVELS AND PSEUDOTUMOR CHARACTERISTICS VARY DUE TO METAL ION SOURCE MODULAR FEMORAL NECK VS METAL-ON-METAL ARTICULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617637 PROFEMUR MODULAR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. PHAC12XX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention