BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD -6MM NK

    MDR report key: 3103538 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01313
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    December 23, 2011
    Report Date
    December 11, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY A CORRECTION AND ADDITIONAL ALLEGATIONS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: INITIAL INFORMATION RECEIVED INDICATED THE (B)(6) 2003 IMPLANT, WHICH WAS REVISED (B)(6) 2011 INVOLVED THE RIGHT HIP. NEW INFORMATION RECEIVED (B)(6) 2013 REPORTS THIS WAS THE LEFT HIP. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 1 STATES; "MATERIAL SENSITIVITY REACTIONS," NUMBER 2 STATES; ¿EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION,¿ NUMBER 10 STATES; ¿FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN 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 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01313 & 04726).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE PATIENT'S BLOOD TEST RESULTS. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01313 & 04726).

    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 WARNINGS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE CORRECTED REVISION DATE AND THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION OF THE HEAD WAS PERFORMED (B)(6) 2012 DUE TO UNKNOWN METAL COMPLICATIONS. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO CORROSION AT THE HEAD AND TAPER JUNCTION. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION FROM THE PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2003, AND AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN IN GROIN AREA AND HIP, TROUBLE WALKING, ELEVATED METAL ION LEVELS, INFLAMMATION, COMPLICATIONS WITH LEFT HIP, PROBLEMS SITTING, STANDING, MOVING UP AND DOWN STAIRS. ADDITIONAL INFORMATION FROM THE PATIENT¿S OPERATIVE REPORT INDICATE REVISION OF LEFT HIP ON DECEMBER 23, 2011 WAS DUE TO ADVERSE REACTION TO METAL IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION OF THE HEAD WAS PERFORMED (B)(6) 2011 DUE TO UNKNOWN METAL COMPLICATIONS. INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO CORROSION AT THE HEAD AND TAPER JUNCTION. ADDITIONAL INFORMATION FROM THE PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2003, AND AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN IN GROIN AREA AND HIP, TROUBLE WALKING, ELEVATED METAL ION LEVELS, INFLAMMATION, COMPLICATIONS WITH LEFT HIP, PROBLEMS SITTING, STANDING, MOVING UP AND DOWN STAIRS. 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

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. A SUBSEQUENT REVISION OF THE HEAD WAS PERFORMED (B)(6) 2012 DUE TO UNKNOWN METAL COMPLICATIONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION OF THE HEAD WAS PERFORMED (B)(6) 2011 DUE TO UNKNOWN METAL COMPLICATIONS. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO CORROSION AT THE HEAD AND TAPER JUNCTION. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203639 M2A 38MM MODULAR HEAD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 178920

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R