BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 3980490 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06819
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    September 25, 2012
    Report Date
    July 15, 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 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 "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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04122 /-06819).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006, AND A REVISION PROCEDURE ON (B)(6) 2010, DUE TO PATIENT ALLEGATIONS OF PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 DUE TO ADVERSE REACTION TO METAL ON METAL. OPERATIVE REPORT NOTED THE PRESENCE OF AN EFFUSION, TURBID FLUID, METALLOSIS STAINED TISSUE, PSEUDOCAPSULE, RETROVERTED CUP, BONY ACETABULUM DEFICIENCIES. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR¿S ACETABULAR COMPONENTS AND A BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456925 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 817610

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R