BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3140748 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01772
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01770 / 01775).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE LEFT INITIAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2004 AND THE RIGHT INITIAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2007. SUBSEQUENTLY, PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2012 DUE TO UNKNOWN REASONS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE ON THE RIGHT HIP. NO FURTHER INFORMATION HAS BEEN PROVIDED 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
    241632 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 001060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R