BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 54MM

    MDR report key: 3905501 · Received July 1, 2014

    Report

    Report Number
    0001825034-2014-05794
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 10, 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
    MO, 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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: MATERIAL SENSITIVITY REACTIONS. INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 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 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05791 / 05794).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, IMPAIRMENT AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL RIGHT HIP SURGERY DATE. INVOICE HISTORY REVEALED THAT A LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2006. AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE RIGHT HIP REVISION SURGERY DATE OR TO CONFIRM WHICH COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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
    384287 M2A-MAGNUM MOD HD SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 545370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization