BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TAPER INSERT-6

    MDR report key: 3211753 · Received July 8, 2013

    Report

    Report Number
    0001825034-2013-02534
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    June 11, 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
    PA, 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 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 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02533 / 02535).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A RIGHT REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION IN REVISION OPERATIVE NOTES INDICATE THE SURGEON NOTED METALLOSIS AND THAT A METAL STAINED CYSTIC MASS WAS REMOVED FROM THE PATIENT¿S WOUND. REVISION OPERATIVE NOTES FURTHER INDICATE OSTEOLYSIS OF THE PROXIMAL FEMUR WITH REACTIVE TISSUE AROUND THE UPPER PORTION OF THE FEMORAL COMPONENT. THE ACETABULAR CUP, MODULAR HEAD, AND TAPER INSERT WERE REMOVED AND REPLACED. 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 REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A RIGHT REVISION PROCEDURE OCCURRED ON (B)(6) 2013, DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. 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
    311021 M2A-MAGNUM 42-50MM TAPER INSERT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 057730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R