BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3820102 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04359
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    October 16, 2012
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "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. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-04493/-04494 & 2014-04359/-04260).

    Additional Manufacturer Narrative · 1

    THE 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 THE PATIENT REPORTED PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PERSONAL INJURIES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 AND A LEFT HIP REVISION ON (B)(6) 2012, DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION,DAMAGE TO SURROUNDING BONE AND TISSUE, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PERSONAL INJURIES. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 AND A LEFT HIP REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 AND A LEFT HIP REVISION ON (B)(6) 2012 DUE TO PAIN AND ADVERSE TISSUE REACTION. LEFT HIP OPERATIVE REPORT NOTED THE PRESENCE OF FLUID AND METALLIC DEBRIS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR'S ACETABULAR SYSTEM AND A BIOMET HEAD. RIGHT HIP OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR AND STRAW-COLORED FLUID, SYNOVITIS AND A LOOSE ACETABULAR CUP. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR'S ACETABULAR SYSTEM AND A BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300047 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 227920

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R