BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3830451 · Received May 23, 2014

    Report

    Report Number
    0001825034-2014-04752
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 19, 2014
    Report Date
    July 11, 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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ 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 NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04751 / 04752).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING AND METALLOSIS. 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 PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING AND METALLOSIS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT HIP REVISION PERFORMED ON (B)(6) 2014 WAS DUE TO PAIN, METAL-ON-METAL REACTION, AND ELEVATED LEVELS OF CHROMIUM AND COBALT. THE PATIENT'S OPERATIVE REPORT NOTED SYNOVITIS, BLACKENED SYNOVIUM, METAL-ON-METAL DEBRIS, BLACKENED TO BROWN FLUID, AND BONE LOSS. 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
    307621 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 057470

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R