BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 3924451 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06082
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 20, 2013
    Report Date
    July 8, 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
    NY, 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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND " UNDESIRABLE SHORTENING OF LIMB.¿ 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 1825034-2014-02041 /-05112 /-06081 /-06082).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL IONS, LACK OF MOBILITY, PAIN, DYSFUNCTION, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO PAIN, LOOSENING, STEM SUBSIDENCE AND LEG LENGTH DISCREPANCY. OP REPORT NOTED THE PRESENCE OF SCAR TISSUE, NO EVIDENCE OF METALLOSIS AND THE ACETABULAR CUP WAS STABLE AND REMAINS IMPLANTED. THE MODULAR HEAD, TAPER ADAPTER AND STEM WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401606 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 058120

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R