BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 3800988 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03766
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 23, 2012
    Report Date
    July 11, 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
    NY, US
    Reporter Occupation
    ATTORNEY

    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. 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: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "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 3 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-01404, 03765 / 03766 AND 06336).

    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. PRODUCT / LOT CODE / EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "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 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01404-2/ -03765/ -03766).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 ALLEGEDLY DUE TO PAIN. THE MODULAR HEAD WAS 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 FROM PATIENT¿S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2014 AND A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2012, DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 ALLEGEDLY DUE TO PAIN. THE MODULAR HEAD WAS 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 FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2014 AND A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT HIP REVISION PERFORMED ON (B)(6) 2014 WAS DUE TO PAIN, METALLOSIS, SOFT TISSUE DESTRUCTION, AND ELEVATED METAL ION LEVELS. THE PATIENT'S OPERATIVE REPORT NOTED CLOUDY FLUID AND METAL STAINING. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE LEFT HIP REVISION PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN WITH METALLOSIS AND METAL-ON-METAL WEAR. THE PATIENT'S OPERATIVE REPORT NOTED FLUID, METALLOSIS, GRANULOMATOUS REACTION AND EROSION INTO THE PROXIMAL FEMUR. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2012 AND (B)(6) 2013 PATIENT'S BLOOD WAS TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277287 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 533140

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R