BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 3800267 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03751
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    July 15, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN; PMA/510(K) NUMBER / MANUFACTURE DATE ¿ UNKNOWN. 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 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03751 / 03755).

    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. 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 1 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03751 / 03755 AND 06942).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, WEIGHT GAIN, LEG LENGTH DISCREPANCY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS AN UNSUCCESSFUL RIGHT HIP REVISION PROCEDURE WAS ATTEMPTED (B)(6) 2009; HOWEVER, THE TAPER ADAPTER WOULD NOT DISENGAGE FROM THE TRUNNION OF THE FEMORAL COMPONENT. ALL COMPONENTS REMAIN IMPLANTED. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. 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 PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, WEIGHT GAIN, LEG LENGTH DISCREPANCY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS AN UNSUCCESSFUL RIGHT HIP REVISION PROCEDURE WAS ATTEMPTED (B)(6) 2009; HOWEVER, THE TAPER ADAPTER WOULD NOT DISENGAGE FROM THE TRUNNION OF THE FEMORAL COMPONENT. ALL COMPONENTS REMAIN IMPLANTED. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS CONFIRM THE UNSUCCESSFUL RIGHT HIP REVISION WAS ATTEMPTED ON (B)(6) 2009, ALL COMPONENTS REMAIN IMPLANTED. ADDITIONAL INFORMATION IN PATIENT MEDICAL RECORDS PROVIDED PRODUCT IDENTIFICATION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2012 PATIENT'S BLOOD WAS TESTED. 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
    277115 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 198580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention