BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D.

    MDR report key: 2651392 · Received July 11, 2012

    Report

    Report Number
    0001825034-2012-01029
    Event Type
    Injury
    Date Received
    July 11, 2012
    Date of Event
    September 10, 2012
    Report Date
    June 14, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY A REVISION PROCEDURE OCCURRED AND THE CUP WAS NOT REMOVED, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01029-1 / 01030-1).

    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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01030 AND 01034). THE USER FACILITY WAS NOTIFIED OF THE EVENT . IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, PATIENT ALLEGES INCREASED METAL ION LEVELS. IT IS UNKNOWN WHETHER A REVISION PROCEDURE HAS OCCURRED. 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 THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGED ELEVATED METAL ION LEVELS, PAIN, DISCOMFORT, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. THE HEAD WAS REMOVED AND REPLACED WITH A BIOMET HEAD AND LINER WHILE THE CUP REMAINS IMPLANTED. 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
    1 M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 668170

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R