BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD -3MM NK

    MDR report key: 3971512 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06542
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    September 16, 2013
    Report Date
    October 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS."

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES. ALTHOUGH MECHANICAL TESTING DEMONSTRATES THAT METAL ON METAL ARTICULATING SURFACES PRODUCE A RELATIVELY LOW AMOUNT OF PARTICLES, THE TOTAL AMOUNT OF PARTICULATE PRODUCED IN VIVO THROUGHOUT THE SERVICE LIFE OF THE IMPLANTS REMAINS UNDETERMINED. THE LONG-TERM BIOLOGICAL EFFECTS OF THE PARTICULATE AND METAL IONS ARE UNKNOWN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. DEVICE NOT RETURNED BY ATTORNEY

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEAL THE LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2013. THE PATIENT'S OPERATIVE REPORT NOTED YELLOWISH FLUID, SOFT TISSUE REACTION, AND CORROSION ON THE TRUNNION AND THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447662 M2A 38MM MODULAR HEAD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 908420

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention