BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 48MM

    MDR report key: 3973858 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06722
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    March 9, 2009
    Report Date
    November 4, 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
    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. 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 1825034-2014-06721 / -06722).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DYSFUNCTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE PROCEDURE DATES AND INDICATES 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DYSFUNCTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE PROCEDURE DATES AND INDICATES 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 OPERATIVE (OP) NOTES REPORTS PATIENT WAS REVISED DUE TO PAIN AND A LOOSE ACETABULAR CUP. REVISION OP REPORT NOTES THE PRESENCE OF FLUID, METALLOSIS, FIBROUS TISSUE, AND A VERTICAL CUP. THE CUP AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450360 M2A-MAGNUM MODULAR HEAD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 999170

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R