BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD+9MM NK NO SKRT

    MDR report key: 3351822 · Received September 17, 2013

    Report

    Report Number
    0001825034-2013-03814
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    January 7, 2011
    Report Date
    December 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP IS TO REPORT INFORMATION ON PATIENT¿S OPERATIVE REPORT FOR (B)(6) 2005 REVISION AND THE (B)(6) 2011 REVISION. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03812 & 03814/ 003815).

    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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." 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." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03812 & 03814/ 003815).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2005 DUE TO AN UNKNOWN REASON. PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT FURTHER REVISION ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORIES CONFIRMED THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED IN BOTH REVISION PROCEDURES. 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 REPORTED PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2005 DUE TO AN UNKNOWN REASON. PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT FURTHER REVISION ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORIES CONFIRMED THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED IN BOTH REVISION PROCEDURES. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS REASON FOR THE (B)(6) 2005 REVISION WAS DUE TO IMPROPER SEATING OF THE ACETABULAR COMPONENT. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS A CYST AND AN ANTERIOR OSTEOPHYTE DURING THE (B)(6) 2005 REVISION. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS DARK-COLORED FLUID, GROSS PROXIMAL OSTEOLYSIS FROM METALLIC WEAR DEBRIS, AND DARK-COLORED TISSUE LINING DURING THE (B)(6) 2011 REVISION. 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
    466576 M2A 38MM MOD HD+9MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 623480

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R