BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INS STD

    MDR report key: 3232113 · Received July 17, 2013

    Report

    Report Number
    0001825034-2013-02733
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    December 10, 2012
    Report Date
    June 17, 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
    CA, 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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02732 / 2734). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, FLUID, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS A SECOND REVISION WAS PERFORMED ON (B)(6) 2013, DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN REPORTED. 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
    330642 M2A-MAGNUM 52-60MM TPR INS STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 582130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R