BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX52MM CUP

    MDR report key: 2894069 · Received January 3, 2013

    Report

    Report Number
    0001825034-2012-02675
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    January 28, 2013
    Report Date
    July 16, 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
    US
    Reporter Occupation
    PATIENT

    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

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT 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." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02675 / 02678). 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

    PATIENT REPORTS TO HAVE UNDERGONE RIGHT HIP ARTHROPLASTY ON (B)(6), 2004 AND LEFT HIP ARTHROPLASTY ON (B)(6), 2004. PATIENT FURTHER ALLEGES ELEVATED COBALT AND CHROMIUM LEVELS AND METALLOSIS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH THE PRIMARY PROCEDURE DATES. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S LEGAL COUNSEL ALLEGES PATIENT ALLEGATIONS OF A SWOLLEN AND DRAINING SINUS TRACT IN THE RIGHT HIP. LEGAL COUNSEL FOR THE PATIENT ALLEGES PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6), 2013. LEGAL COUNSEL ALLEGES A DRAINING SINUS WITH MEMBRANE AND INFECTED JOINT FLUID WERE ALLEGEDLY NOTED DURING THE REVISION. REVIEW OF INVOICE HISTORY COULD NOT CONFIRM A PROCEDURE OCCURRING ON OR ABOUT (B)(6), 2013. 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

    PATIENT REPORTS TO HAVE UNDERGONE RIGHT HIP ARTHROPLASTY ON (B)(6) 2004 AND LEFT HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT FURTHER ALLEGES ELEVATED COBALT AND CHROMIUM LEVELS AND METALLOSIS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH THE PRIMARY PROCEDURE DATES. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S LEGAL COUNSEL ALLEGES PATIENT ALLEGATIONS OF A SWOLLEN AND DRAINING SINUS TRACT IN THE RIGHT HIP. LEGAL COUNSEL FOR THE PATIENT ALLEGES PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2013. LEGAL COUNSEL ALLEGES A DRAINING SINUS WITH MEMBRANE AND INFECTED JOINT FLUID WERE ALLEGEDLY NOTED DURING THE REVISION. REVIEW OF INVOICE HISTORY COULD NOT CONFIRM A PROCEDURE OCCURRING ON OR ABOUT (B)(6) 2013. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2013 DUE TO ADVERSE LOCAL TISSUE REACTION. OPERATIVE REPORT NOTED THE PRESENCE OF FLUID. ALL COMPONENTS WERE REMOVED AND REPLACED WITH SPACER MOLDS. OPERATIVE REPORT NOTED HIP WAS REIMPLANTED ON (B)(6) 2013 WITH COMPETITOR'S COMPONENTS. ADDITIONAL OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO ADVERSE LOCAL TISSUE REACTION AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF SCAR TISSUE, OSTEOLYSIS, METALLIC DEBRIS, AND SEROSANGUINEOUS FLUID WITH CLOUDY CLUMPS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR'S CUP AND A BIOMET HEAD.

    Description of Event or Problem · 1

    PATIENT REPORTS TO HAVE UNDERGONE RIGHT HIP ARTHROPLASTY ON (B)(6) 2004 AND LEFT HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT FURTHER ALLEGES ELEVATED COBALT AND CHROMIUM LEVELS AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH THE PRIMARY PROCEDURE DATES. 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
    2167 M2A 38MMX52MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 030730

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability