BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TAPER INSERT-6

    MDR report key: 2991512 · Received March 6, 2013

    Report

    Report Number
    0001825034-2013-00475
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    August 21, 2012
    Report Date
    July 12, 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
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. BIOMET PACKAGE INSERT CONTAINS THE FOLLOWING POSSIBLE ADVERSE EFFECTS: ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES. ALTHOUGH MECHANICAL TESTING DEMONSTRATES THAT METAL-ON-METAL ARTICULATING SURFACES PRODUCE A RELATIVELY LOW AMOUNT OF PARTICLES, THE TOTAL AMOUNT OF PARTICULATE PRODUCED IN VIVO THROUGHOUT THE SERVICE LIFE OF THE IMPLANTS REMAINS UNDETERMINED. THE LONG-TERM BIOLOGICAL EFFECTS OF THE PARTICULATE AND METAL IONS ARE UNKNOWN. PACKAGE INSERT ALSO INCLUDES: EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00473 / 00477).

    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. THIS REPORT IS NUMBER 3 OF 8 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00473 / -00477 AND 1825034-2014-06410, -06412, AND -06421).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A LEFT HIP REVISION PROCEDURE WAS ATTEMPTED ON (B)(6) 2012 DUE TO ELEVATED METAL IONS; HOWEVER, THE SURGEON WAS UNABLE TO SEPARATE AND REMOVE THE COMPONENTS AND THE PATIENT WAS CLOSED. THE LEFT HIP COMPONENTS WERE SUCCESSFULLY REVISED ON (B)(6) 2012 AND REPLACED WITH A CEMENT SPACER AS THE PATIENT HAD DEVELOPED AN INFECTION. THE PATIENT UNDERWENT ANOTHER HIP ARTHROPLASTY PROCEDURE TO IMPLANT NEW LEFT HIP COMPONENTS AND REMOVE CEMENT SPACER ON (B)(6) 2012. A SUBSEQUENT REVISION TO EXCHANGE THE MODULAR HEAD WAS PERFORMED ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A LEFT HIP REVISION PROCEDURE WAS ATTEMPTED ON (B)(6) 2012 DUE TO ELEVATED METAL IONS; HOWEVER, THE SURGEON WAS UNABLE TO SEPARATE AND REMOVE THE COMPONENTS AND THE PATIENT WAS CLOSED. THE LEFT HIP COMPONENTS WERE SUCCESSFULLY REVISED ON (B)(6) 2012 AND REPLACED WITH A CEMENT SPACER AS THE PATIENT HAD DEVELOPED AN INFECTION. THE PATIENT UNDERWENT ANOTHER HIP ARTHROPLASTY PROCEDURE TO IMPLANT NEW LEFT HIP COMPONENTS AND REMOVE CEMENT SPACER ON (B)(6) 2012. A SUBSEQUENT REVISION TO EXCHANGE THE MODULAR HEAD WAS PERFORMED ON (B)(6) 2012. IN ADDITION, THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96195 M2A-MAGNUM 42-50MM TAPER INSERT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 760000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R