BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 3232584 · Received July 18, 2013

    Report

    Report Number
    0001825034-2013-02729
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    February 2, 2012
    Report Date
    June 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01419, 1825034-2013-02729 / 02731).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01419, 1825034-2013-02729 / 02731).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. A SUBSEQUENT REVISION TO THE RIGHT HIP WAS PERFORMED ON (B)(6) 2012 DUE TO PSEUDOTUMOR AND CAPSULAR NECROSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION TO THE RIGHT HIP WAS PERFORMED (B)(6) 2012 DUE TO PSEUDOTUMOR AND CAPSULAR NECROSIS. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DIFFICULTY WALKING AND DIFFICULTY SLEEPING. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL REPORTS PATIENT HAD ELEVATED METAL IONS AT TIME OF RIGHT HIP REVISION. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL IN THE FORM OF BLOOD TEST RESULTS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE RIGHT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN AND MECHANICAL COMPLICATION. THE PATIENT¿S OPERATIVE REPORT NOTED MILKY TAN FLUID, NECROSIS AND PSEUDOTUMOR. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY (B)(6), 2003. A SUBSEQUENT REVISION TO THE RIGHT HIP WAS PERFORMED (B)(6), 2012 DUE TO PSEUDOTUMOR AND CAPSULAR NECROSIS. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DIFFICULTY WALKING AND DIFFICULTY SLEEPING. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL REPORTS PATIENT HAD ELEVATED METAL IONS AT TIME OF RIGHT HIP REVISION. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL IN THE FORM OF BLOOD TEST RESULTS. 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
    333687 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 631600

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R