BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 3833809 · Received May 27, 2014

    Report

    Report Number
    0001825034-2014-04753
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    January 26, 2009
    Report Date
    July 17, 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
    AL, 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: 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 NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04753 / 04756).

    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.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, ELEVATED METAL ION LEVELS, DIFFICULTY SITTING, STANDING, AND MOVING UP AND DOWN STAIRS. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. 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 ON THE RIGHT SIDE DUE TO INSTABILITY. OP REPORT NOTES THE ACETABULAR COMPONENT WAS FOUND IN A NEUTRAL POSITION, WHICH IS CONSISTENT WITH REPORTS OF INSTABILITY. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2009, DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, ELEVATED METAL ION LEVELS, DIFFICULTY SITTING, STANDING, AND MOVING UP AND DOWN STAIRS. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311419 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 777940

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R