BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 54MM

    MDR report key: 3821855 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04437
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    July 31, 2013
    Report Date
    July 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 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 NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04434 / 04437).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY IN (B)(6) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY IN (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. A REVIEW OF INVOICE HISTORY INDICATES THE LEFT HIP ARTHROPLASTY WAS ON (B)(6) 2009 AND THE RIGHT HIP ARTHROPLASTY WAS ON (B)(6) 2009. INVOICE HISTORY FURTHER CONFIRMED THE RIGHT HIP REVISION PROCEDURE OF (B)(6) 2013. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. MEDICAL RECORDS RECEIVED NOTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES IN 1996. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2009 DUE TO PAIN, METAL DEBRIS AND WEAR. OPERATIVE REPORT NOTED THE PREVIOUS STEM WAS LOOSE AND THE PRESENCE OF FLUID AND GRANULATION TISSUE. COMPETITOR'S COMPONENTS WERE REMOVED AND A BIOMET STEM, ACETABULAR CUP AND MODULAR HEAD WERE IMPLANTED. AN ADDITIONAL OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2009 DUE TO DISLOCATIONS AND WEAR. OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR FLUID, BONE LOSS AND A FRACTURED GREATER TROCHANTER. COMPETITOR'S COMPONENTS WERE REMOVED AND A BIOMET STEM, ACETABULAR CUP AND MODULAR HEAD WERE IMPLANTED. ADDITIONAL OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT AN ADDITIONAL RIGHT HIP REVISION ON (B)(6) 2013 DUE TO PAIN AND THE INABILITY TO WALK. OPERATIVE REPORT NOTED THE PRESENCE OF METAL DEBRIS, UNHEALTHY TISSUE, BROWNISH FLUID, LOOSE CABLE AND A LOOSE ACETABULAR CUP DUE TO LACK OF BONY INGROWTH, METALLOSIS AND OSTEOLYSIS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY IN (B)(6) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY IN (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013, DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS METAL POISONING AND METALLOSIS. A REVIEW OF INVOICE HISTORY INDICATES THE LEFT HIP ARTHROPLASTY WAS ON (B)(6) 2009 AND THE RIGHT HIP ARTHROPLASTY WAS ON (B)(6) 2009. INVOICE HISTORY FURTHER CONFIRMED THE RIGHT HIP REVISION PROCEDURE OF (B)(6) 2013. 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
    300308 M2A-MAGNUM MOD HEAD SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 656330

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R