BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 2894723 · Received January 3, 2013

    Report

    Report Number
    0001825034-2012-02683
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    September 18, 2008
    Report Date
    December 12, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. 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 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02682 / 02683 & 1825034-2013-02894). THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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 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." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02682 / 02683). THE 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 REPORTS A BILATERAL PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003 AND LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2004. SUBSEQUENTLY, PATIENT ALLEGES REVISION OF LEFT HIP ON (B)(6) 2008 AND THE RIGHT HIP ON (B)(6) 2011 ALLEGEDLY DUE TO PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. REVIEW OF PATIENT OPERATIVE NOTES INDICATES THE LEFT HIP REVISION ON (B)(6) 2008 WAS DUE TO METALLOSIS AND LOOSENING OF THE CUP. THE HEAD AND CUP WERE REMOVED AND REPLACED. OPERATIVE NOTES INDICATE THE RIGHT HIP REVISION ON (B)(6) 2011 WAS DUE TO LOOSENING OF THE CUP. THE HEAD AND THE CUP WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES, RIGHT SIDE, ON (B)(6) 2003 AND THE LEFT SIDE ON (B)(6) 2004. SUBSEQUENTLY, PATIENT ALLEGES REVISION OF RIGHT HIP ON (B)(6) 2008 AND THE LEFT HIP ON (B)(6) 2011 ALLEGEDLY DUE TO PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3677 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 384190

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R