BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 3188623 · Received June 25, 2013

    Report

    Report Number
    0001825034-2013-02235
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    January 8, 2009
    Report Date
    November 18, 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
    ATTORNEY

    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. 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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 9 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-02087-1, 02247-1/02250-1 AND 2013-02232/02235).

    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

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2007. A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2008, ALLEGEDLY DUE TO INFECTION AND CUP LOOSENING. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2009, ALLEGEDLY DUE TO MALPOSITION OF THE ACETABULAR CUP, PSEUDO CAPSULE AND GRAYISH FLUID. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. A SUBSEQUENT RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012, FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012, WAS DUE METALLOSIS, ELEVATED METAL IONS, AND ACETABULAR CUP LOOSENING. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2007. A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2008 ALLEGEDLY DUE TO INFECTION AND CUP LOOSENING. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2009 ALLEGEDLY DUE TO MALPOSITION OF THE ACETABULAR CUP, PSEUDO CAPSULE AND GRAYISH FLUID. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. A SUBSEQUENT RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE METALLOSIS, ELEVATED METAL IONS, AND ACETABULAR CUP LOOSENING. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2008 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP. REVISION OP REPORT NOTES A LOOSE ACETABULAR COMPONENT, FIBRINOUS MATERIAL, SCAR TISSUE WITHIN THE JOINT THAT AFFECTED STABILITY, AND A TARNISHED PORTION UNDER THE HEAD THAT MADE REMOVAL DIFFICULT. ADDITIONAL INFORMATION RECEIVED IN RIGHT HIP REVISION NOTES DATED (B)(6) 2012 REPORTS THE PRESENCE OF BROWNISH FLUID WITHIN THE JOINT; NECROTIC DEBRIS; GRAYISH TISSUE CONSISTENT WITH METAL ION DISEASE; AND A LOOSE, VERTICAL ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288670 M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 627940

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R