BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER

    MDR report key: 2495906 · Received March 20, 2012

    Report

    Report Number
    0001825034-2012-00287
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    February 17, 2012
    Report Date
    January 30, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY AN ADDITIONAL REASON FOR THE REVISION PROCEDURE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FIFTEEN STATES, "METAL ON METAL ARTICULATING SURFACES HAVE LIMITED CLINICAL HISTORY. ALTHOUGH MECHANICAL TESTING DEMONSTRATES THAT METAL ON METAL ARTICULATING SURFACES PRODUCE A RELATIVELY LOW AMOUNT OF PARTICLES, THE TOTAL AMOUNT OF PARTICULATE PRODUCED REMAINS UNDETERMINED. BECAUSE OF THE LIMITED CLINICAL AND PRECLINICAL EXPERIENCE, THE LONG-TERM BIOLOGICAL EFFECTS OF THE PARTICULATE ARE UNKNOWN". THIS FOLLOW UP REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00286-1 / 00287-1).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER ONE STATES, "MATERIAL SENSITIVITY REACTIONS. PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID". NUMBER EIGHT STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS". NUMBER FOURTEEN STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN". THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00286 / 00287). THE USER FACILITY WAS NOTIFIED OF THE EVENT ON MARCH 1, 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    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

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 DUE TO INCREASING DISCOMFORT AND A SQUEAKING SENSATION IN HIS HIP. DURING THE PROCEDURE, THE HIP WAS NOTED TO SUBLUXATE ANTERIORLY WITH EXTENSION AND EXTERNAL ROTATION. THE ACETABULAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED. THE HIP STEM REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6), 2003. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6), 2012 DUE TO INCREASING DISCOMFORT AND A SQUEAKING SENSATION IN HIS HIP, AS WELL AS INCREASED METAL ION LEVELS. DURING THE PROCEDURE THE HIP WAS NOTED TO SUBLUXATE ANTERIORLY WITH EXTENSION AND EXTERNAL ROTATION. THE ACETABULAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED. THE HIP STEM REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 373330

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R