BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD -3MM NK

    MDR report key: 3973853 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06711
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    December 10, 2012
    Report Date
    October 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: THE FOLLOWING ARE LISTED UNDER POSSIBLE ADVERSE EFFECTS: ¿MATERIAL SENSITIVITY REACTIONS.¿ AND ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES.¿ AND ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ AND ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE (REFERENCE 1825034-2014-06710 / -06711).

    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, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ NUMBER 10 STATES, ¿FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2005 AND A REVISION PROCEDURE ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL THE (B)(6) 2012 REVISION WAS DUE TO PAIN AND CYSTIC OSTEOLYTIC AREAS. THE PATIENT'S OPERATIVE REPORT NOTED CLOUDY FLUID, CORROSION ON THE TAPER OF FEMORAL COMPONENT, AND LOOSE ACETABULAR COMPONENT WITH NO BONY INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450411 M2A 38MM MODULAR HEAD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 309160

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R