BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3870436 · Received June 12, 2014

    Report

    Report Number
    0001825034-2014-05487
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    October 19, 2012
    Report Date
    August 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." 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 A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD AND TAPER ADAPTER 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 A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD AND TAPER ADAPTER 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 INDICATES THAT RIGHT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN, FATIGUE, ACHINESS, SWELLING, AND ELEVATED CHROMIUM AND COBALT LEVELS. THE PATIENT'S OPERATIVE REPORT NOTED A CYST. ADDITIONAL INFORMATION RECEIVED NOTED THAT ON (B)(6) 2012 PATIENT'S BLOOD WAS TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348042 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 508000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R